Insulin management
Summary by NHIP
Insulin Bolus Adjustment Method
The method determines blood glucose types from glucometer readings to calculate next-day meal bolus adjustments. It specifically calculates an adjustment factor when a subsequent measurement of the immediately subsequent blood glucose type is received during the current day.
Claim Score by NHIP
Abstract
A method of administering insulin includes receiving blood glucose measurements of a patient at a data processing device from a glucometer. The blood glucose measurements are separated by a time interval. The method also includes receiving patient information at the data processing device and selecting a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The selection includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment.

Term
8.1 yearsleft in the term
Expires 27 October 2034.
- Priority
- Filed
- Granted
- Today
- Expires
20 claims: 2 independent, 18 dependent
- 1Broadest claimClaim Score 17, narrow(NHIP)A method comprising:receiving, at data processing hardware, a blood glucose measurement of a patient from a glucometer;determining, by the data processing hardware, a blood glucose type of the received blood glucose measurement;when the determined blood glucose type comprises one of a pre-breakfast blood glucose measurement, a pre-lunch blood glucose measurement, or a pre-dinner blood glucose measurement: determining, by the data processing hardware, whether a subsequent blood glucose measurement associated with an immediately subsequent blood glucose type has been received from the glucometer during a current day, the immediately subsequent blood glucose type comprising one of: the pre-lunch blood glucose measurement when the determined blood glucose type comprises the pre-breakfast blood glucose measurement;the pre-dinner blood glucose measurement when the determined blood glucose type comprises the pre-lunch blood glucose measurement;or a bedtime blood glucose measurement when the determined blood glucose type comprises the pre-dinner blood glucose measurement;when the subsequent blood glucose measurement associated with the immediately subsequent blood glucose type has been received, determining, by the data processing hardware, an adjustment factor for adjusting a next day's recommended meal bolus for the determined blood glucose type governed by the subsequent blood glucose measurement for the immediately subsequent blood glucose type;determining, by the data processing hardware, the next day's recommended meal bolus at the time of day associated with the determined blood glucose type by multiplying a current day's recommended meal bolus associated with the determined blood glucose type times the adjustment factor;and transmitting the next day's recommended meal bolus to an administration device in communication with the data processing hardware on the next day at the time of day associated with the determined blood glucose type, the administration device comprising: a doser;and an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer a number of units of insulin to the patient using the next day's recommended meal bolus.
- 11A system comprising:a glucometer measuring blood glucose measurements separated by a time interval;and a dosing controller in communication with the glucometer, the dosing controller including data processing hardware and memory hardware in communication with the data processing hardware, the dosing controller configured to perform operations comprising: receiving a blood glucose measurement of a patient from a glucometer;determining a blood glucose type of the received blood glucose measurement;when the determined blood glucose type comprises one of a pre-breakfast blood glucose measurement, a pre-lunch blood glucose measurement, or a pre-dinner blood glucose measurement: determining whether a subsequent blood glucose measurement associated with an immediately subsequent blood glucose type has been received from the glucometer during a current day, the immediately subsequent blood glucose type comprising one of: the pre-lunch blood glucose measurement when the determined blood glucose type comprises the pre-breakfast blood glucose measurement;the pre-dinner blood glucose measurement when the determined blood glucose type comprises the pre-lunch blood glucose measurement;or a bedtime blood glucose measurement when the determined blood glucose type comprises the pre-dinner blood glucose measurement;when the subsequent blood glucose measurement associated with the immediately subsequent blood glucose type has been received, determining an adjustment factor for adjusting a next day's recommended meal bolus for the determined blood glucose type governed by the subsequent blood glucose measurement for the immediately subsequent blood glucose type;determining the next day's recommended meal bolus at the time of day associated with the determined blood glucose type by multiplying a current day's recommended meal bolus associated with the determined blood glucose type times the adjustment factor;and transmitting the next day's recommended meal bolus to an administration device in communication with the dosing controller on the next day at the time of day associated with the determined blood glucose type, the administration device comprising: a doser;and an administration computing device in communication with the doser, the administration computing device configured to cause the doser to administer a number of units of insulin to the patient using the next day's recommended meal bolus.
Independent claims2
280 paragraphs in 6 sections, as filed
CROSS REFERENCE TO RELATED APPLICATIONS
0001This U.S. patent application is a continuation of, and claims priority under 35 U.S.C. § 120 from, U.S. patent application Ser. No. 15/342,606, filed on Nov. 3, 2016, which is a continuation of U.S. patent application Ser. No. 14/938,997, filed on Nov. 12, 2015, which is a divisional under 35 U.S.C. § 121 of U.S. patent application Ser. No. 14/524,918, filed on Oct. 27, 2014, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application 61/934,300, filed on Jan. 31, 2014, and U.S. Provisional Application 62/009,575, filed on Jun. 9, 2014. The disclosures of these prior applications are considered part of the disclosure of this application and are hereby incorporated by reference in their entireties.
TECHNICAL FIELD
0002This disclosure relates to a system for managing insulin administration or insulin dosing.
BACKGROUND
0003Today, nearly 40% of patients admitted to acute care hospitals in the United States experience either hyperglycemia or hypoglycemia, both serious medical conditions. Many of these patients have diabetes while others have fluctuating blood sugars due to trauma, drug reactions, stress and other factors. Nurses and doctors managing these patients manually calculate insulin doses using complex paper protocols.
0004Manual calculation may not be accurate due to human error, which can lead to patient safety issues. Different institutions use multiple and sometimes conflicting protocols to manually calculate an insulin dosage. Moreover, the protocols may include extra paperwork that nurses and physicians have to manage, which in turn leads to workflow inefficiencies, additional operating costs, and employee satisfaction issues. SCIP (Surgical Care Improvement Project) scores, length of stay, readmission and even mortality rates adversely affect sub-optimal glycemic management.
0005The prevalent method of regulating continuous intravenous insulin infusion is by using a set of written instructions, known as a paper protocol. Paper protocols often involve a tree of conditional statements and some use of tables of numbers, for which a given blood glucose value dictates the use of a different column of insulin rates. The complexity of these paper protocols multiplies the probability of error by the nurses using them. These errors can lead to hypoglycemic events.
SUMMARY
0006One aspect of the disclosure provides a method of administering insulin. The method includes receiving blood glucose measurements of a patient at a data processing device from a glucometer. The blood glucose measurements are separated by a time interval. The method also includes receiving patient information at the data processing device. The method includes selecting, using the data processing device, a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments. The selection is based on the blood glucose measurements and the patient information. The selected subcutaneous insulin treatment includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, a meal-by-meal subcutaneous program with carbohydrate counting, and a subcutaneous program for non-diabetic patients. The subcutaneous standard program includes determining a blood glucose type of the received blood glucose measurement using the data processing device and determining a correction insulin dose based on the blood glucose type using the data processing device. The method also includes executing, using the data processing device, the selected subcutaneous insulin treatment.
0007Implementations of the disclosure may include one or more of the following optional features. In some implementations, the method includes receiving a governing blood glucose value, and determining an adjustment factor based on the received governing blood glucose value. Determining the adjustment factor may include determining when the governing blood glucose value is within a threshold range of values, and setting the adjustment factor to a preconfigured adjustment factor based on the threshold range of values. In some implementations, the method includes determining a Carbohydrate-to-Insulin Ratio based on the adjustment factor. The blood glucose type is associated with a blood glucose time associated with a time of measuring the blood glucose measurement. The blood glucose type is selected from the group consisting of: a pre-breakfast blood glucose measurement, a pre-lunch blood glucose measurement, a pre-dinner blood glucose measurement, a bedtime blood glucose measurement, a midsleep blood glucose measurement and a miscellaneous blood glucose measurement.
0008In some examples, the method includes determining, using the data processing device, if a breakfast blood glucose measurement has been received at the data processing device from the glucometer. When the breakfast blood glucose measurement has been received, the method includes selecting, using the data processing device, a governing blood glucose as a lesser one of a previous midsleep blood glucose measurement or the breakfast blood glucose measurement. The method further includes determining, using the data processing device, an adjustment factor for adjusting a current day's recommended basal dose based on the selected governing blood glucose measurement and retrieving, by the data processing device, a previous day's bed time recommended basal dose. The method further includes determining, by the data processing device, the current day's recommended basal dose by multiplying the adjustment factor times the previous day's bed time recommended basal dose. The current day's recommended basal dose corresponds to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of one, two, or three times per day. When the breakfast blood glucose measurement has not been received, the method includes blocking, using the data processing device, a basal dose recommendation and transmitting a warning from the data processing device to a display in communication with the data processing device. The warning indicates the blocked basal dose recommendation.
0009The method further includes receiving, at the data processing device, a breakfast blood glucose measurement from the glucometer and selecting, using the data processing device, a governing blood glucose as one of a previous midsleep blood glucose measurement and the received breakfast blood glucose measurement. The method also includes, determining, using the data processing device, and adjustment factor for adjusting a current day's recommended basal dose based on the selected governing blood glucose measurement and retrieving, by the data processing device, a previous day's bed time recommended basal dose. The method further includes determining, by the data processing device, the current day's recommended basal dose by multiplying the adjustment factor times the previous day's bed time recommended basal dose. The current day's recommended basal dose corresponds to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of one, two, or three times per day. The governing blood glucose is selected as the previous midsleep blood glucose measurement when the previous midsleep blood glucose measurement is less than the breakfast blood glucose measurement. The governing blood glucose is selected as the breakfast blood glucose measurement when the breakfast blood glucose measurement is less than the previous midsleep blood glucose measurement unless the previous midsleep blood glucose measurement was accompanied by a correction insulin dose exceeding three units of insulin, and an elapsed time between the correction insulin dose and the breakfast blood glucose measurement is less than three hours.
0010When the determined blood glucose type is one of a breakfast blood glucose measurement, a lunch blood glucose measurement, or a dinner blood glucose measurement, the method includes determining, using the data processing device, an adjustment factor for adjusting a next day's recommended meal bolus at a time of day associated with the determined blood glucose type based upon the subsequent blood glucose measurement, after a subsequent blood glucose measurement associated with a subsequent blood glucose type is received. The method also includes determining, by the data processing device, the next day's recommended meal bolus at the time of day associated with the determined blood glucose type by multiplying the current day's recommended meal bolus associated with the determined blood glucose type times the adjustment factor.
0011The subcutaneous program for non-diabetic patients includes, for each blood glucose measurement received by the data processing device from the glucometer that is less than or equal to a threshold value, determining, using the data processing device, new currently-recommended insulin doses by multiplying all currently-recommended insulin doses by a dose reduction factor including a value less than one. The method includes recalculating, using the data processing device, a total daily dose of insulin as a sum of all the new currently-recommended insulin doses. The subcutaneous meal-by-meal without carb-counting program includes determining, using the data processing device, a recommended bolus for use throughout the day. For each meal, the method includes adjusting the meal bolus, using the data processing device, by multiplying an immediately previous recommended meal bolus times an adjustment factor governed by a blood glucose measurement received after an immediately previous meal associated with the immediately previous recommended meal bolus. The subcutaneous meal-by-meal with carb-counting program includes determining, using the data processing device, a carbohydrate-insulin ratio for use throughout the day. For each meal, the method includes adjusting the carbohydrate-insulin ratio, using the data processing device, by dividing an immediately previous carbohydrate-insulin ratio associated with an immediately previous meal by an adjustment factor governed by a blood glucose measurement received after the immediately previous meal.
0012The method further includes transmitting the selected subcutaneous insulin treatment to an administration device in communication with the data processing device. The administration device includes a doser and an administration computing device in communication with the doser. The administration computing device, when executing the selected subcutaneous insulin treatment, causes the doser to administer insulin specified by the selected subcutaneous insulin treatment. The administration device includes at least one of an insulin injection pen or an insulin pump.
0013Another aspect of the disclosure provides a system for administering insulin. The system includes a glucometer measuring blood glucose measurements separated by a time interval and a dosing controller in communication with the glucometer. The dosing controller includes a data processing device and non-transitory memory in communication with the data processing device. The dosing controller receives blood glucose measurements of a patient from the glucometer and receives patient information. The dosing controller further selects a subcutaneous insulin treatment from a collection of subcutaneous insulin treatments based on the blood glucose measurements and the patient information. The selected subcutaneous insulin treatment includes one or more of a subcutaneous standard program, a subcutaneous program without meal boluses, a meal-by-meal subcutaneous program without carbohydrate counting, and a subcutaneous program for non-diabetic patients. During the standard subcutaneous program, the dosing controller determines a blood glucose type of the received blood glucose measurement and determines a correction insulin dose based on the blood glucose type. The dosing controller further includes executing the selected subcutaneous insulin treatment.
0014In some examples, the dosing controller receives a governing blood glucose value and determines an adjustment factor based on the received governing blood glucose value. The dosing controller determines the adjustment factor by determining when the governing blood glucose value is within a threshold range of values and sets the adjustment factor to a pre-configured adjustment factor based on the threshold range of values. The dosing controller further determines the adjustment factor by determining the governing blood glucose value is within one of multiple pre-configured ranges of values and sets the adjustment factor to a pre-configured adjustment factor associated with the pre-configured range of values that includes the governing blood glucose value. In some examples, the dosing controller determines a carbohydrate-to-insulin ratio.
0015The blood glucose type is associated with a blood glucose time associated with a time of measuring the blood glucose measurement. The blood glucose type is selected from the group consisting of: a pre-breakfast blood glucose measurement, a pre-lunch blood glucose measurement, a pre-dinner blood glucose measurement, a bedtime blood glucose measurement, a midsleep blood glucose measurement and a miscellaneous blood glucose measurement.
0016In some implementations, the dosing controller determines if a breakfast blood glucose measurement has been received at the data processing device from the glucometer. When the breakfast blood glucose measurement has been received, the dosing controller selects a governing blood glucose as a lesser one of a previous midsleep blood glucose measurement or the breakfast blood glucose measurement. The dosing controller further determines an adjustment factor for adjusting a current day's recommended basal dose based on the selected governing blood glucose measurement, retrieves a previous day's bed time recommended basal dose and determines the current day's recommended basal dose by multiplying the adjustment factor times the previous day's bed time recommended basal dose. The current day's recommended basal dose corresponds to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of tone, two, or three times per day. When the breakfast blood glucose measurement has not been received, the dosing controller blocks a basal dose recommendation and transmits a warning to a display in communication with the dosing controller. The warning indicates the blocked basal dose recommendation.
0017In some examples, the dosing controller receives a breakfast blood glucose measurement from the glucometer and selects a governing blood glucose as one of a previous midsleep blood glucose measurement or the received breakfast blood glucose measurement. The dosing controller also determines an adjustment factor for adjusting a current day's recommended basal dose based on the selected governing blood glucose measurement and retrieves a previous day's bed time recommended basal dose. The dosing controller further determines the current day's recommended basal dose by multiplying the adjustment factor times the previous day's bed time recommended basal dose. The current day's recommended basal dose corresponds to an insulin dose of long-acting insulin to be administered to the patient at a configurable frequency of one, two, or three times per day. The governing blood glucose is selected as the previous midsleep blood glucose measurement when the previous midsleep blood glucose measurement is less than the breakfast blood glucose measurement. The governing blood glucose is selected as the breakfast blood glucose measurement when the breakfast blood glucose measurement is less than the previous midsleep blood glucose measurement unless the previous midsleep blood glucose measurement was accompanied by a correction insulin dose exceeding three units of insulin and an elapsed time between the correction insulin dose and the breakfast blood glucose measurement is less than three hours.
0018When the determined blood glucose type is one of a breakfast blood glucose measurement, a lunch blood glucose measurement, or a dinner blood glucose measurement, after a subsequent blood glucose measurement associated with a subsequent blood glucose type is received, the dosing controller determines an adjustment factor for adjusting a next day's recommended meal bolus at a time of day associated with the determined blood glucose type based upon the subsequent blood glucose measurement. The dosing controller further determines the next day's recommended meal bolus at the time of day associated with the determined blood glucose type by multiplying the current day's recommended meal bolus associated with the determined blood glucose type times the adjustment factor.
0019During the subcutaneous program for non-diabetic patients, the dosing controller determines a new currently-recommended insulin doses by multiplying all currently-recommended insulin doses by a dose reduction factor including a value less than one and recalculates a total daily dose of insulin as a sum of all the new currently-recommended insulin doses, for each blood glucose measurement received by the dosing controller from the glucometer that is less than or equal to a threshold value. During the subcutaneous meal-by-meal without carb-counting program, the dosing controller determines a recommended meal bolus for use throughout the day. For each meal, the system adjusts the meal bolus by multiplying an immediately previous recommended meal bolus times and adjustment factor governed by a blood glucose measurement received after an immediately previous meal associated with the immediately previous recommended meal bolus. During the subcutaneous meal-by-meal with carb-counting program, the dosing controller determines a carbohydrate-insulin ratio for use throughout the day. For each meal, the system adjust the carbohydrate-insulin ratio by dividing an immediately previous carbohydrate-insulin ratio associated with an immediately previous meal by an adjustment factor governed by a blood glucose measurement received after the immediately previous meal.
0020In some examples, the dosing controller transmits the selected subcutaneous insulin treatment to an administration device in communication with the dosing controller. The administration device includes a doser and an administration computing device in communication with the doser. The administration computing device, when executing the selected subcutaneous insulin treatment, causes the doser to administer insulin specified by the selected subcutaneous insulin treatment. The administration device includes at least one of an insulin injection pen or an insulin pump.
0021The details of one or more implementations of the disclosure are set forth in the accompanying drawings and the description below. Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
0022<figref idref="DRAWINGS">FIG. 1A</figref> is a schematic view of an exemplary system for monitoring blood glucose level of a patient.
0023<figref idref="DRAWINGS">FIG. 1B</figref> is a schematic view of an exemplary system for monitoring blood glucose level of a patient.
0024<figref idref="DRAWINGS">FIG. 1C</figref> is a schematic view of an exemplary administration device in communication with a dosing controller.
0025<figref idref="DRAWINGS">FIG. 2A</figref> is a schematic view of an exemplary process for monitoring the blood glucose level of a patient.
0026<figref idref="DRAWINGS">FIG. 2B</figref> is a schematic view of an exemplary display for inputting patient information.
0027<figref idref="DRAWINGS">FIG. 2C</figref> is a schematic view of an exemplary display for selecting a patient from a list of patients.
0028<figref idref="DRAWINGS">FIG. 3</figref> is a schematic view of an exemplary dose calculation process of <figref idref="DRAWINGS">FIG. 2A</figref>.
0029<figref idref="DRAWINGS">FIG. 4A</figref> is a schematic view of an exemplary calculation of the intravenous time interval of <figref idref="DRAWINGS">FIG. 2A</figref>.
0030<figref idref="DRAWINGS">FIGS. 4B and 4C</figref> are schematic views of an exemplary display showing the time a next blood glucose measurement is due.
0031<figref idref="DRAWINGS">FIG. 4D</figref> is a schematic view of an exemplary display for inputting patient information.
0032<figref idref="DRAWINGS">FIG. 4E</figref> is a schematic view of an exemplary display of patient information and a timer for a patient's next blood glucose measurement.
0033<figref idref="DRAWINGS">FIGS. 5A and 5B</figref> are schematic views of an exemplary meal bolus process of <figref idref="DRAWINGS">FIG. 2A</figref>.
0034<figref idref="DRAWINGS">FIGS. 5C and 5D</figref> are schematic views of exemplary displays requesting information from the user.
0035<figref idref="DRAWINGS">FIGS. 6A and 6B</figref> are schematic views of an exemplary subcutaneous transition process of <figref idref="DRAWINGS">FIG. 2A</figref>.
0036<figref idref="DRAWINGS">FIG. 6C</figref> is a schematic view of an exemplary warning to the user relating to the patient.
0037<figref idref="DRAWINGS">FIG. 6D</figref> is a schematic view of an exemplary display inquiring whether the patient should continue treatment or stop.
0038<figref idref="DRAWINGS">FIG. 6E</figref> is a schematic view of an exemplary display requesting information from the user relating to the patient.
0039<figref idref="DRAWINGS">FIG. 6F</figref> is a schematic view of an exemplary display showing the recommended dose of insulin.
0040<figref idref="DRAWINGS">FIG. 6G</figref> is a schematic view of an exemplary view to the user relating to transitioning a patient to subcutaneous delivery.
0041<figref idref="DRAWINGS">FIG. 7</figref> is a schematic view of an exemplary correction boluses process.
0042<figref idref="DRAWINGS">FIG. 8</figref> is a schematic view of an exemplary adjustment factor process.
0043<figref idref="DRAWINGS">FIGS. 9A and 9B</figref> are a schematic view of an exemplary subcutaneous standard program.
0044<figref idref="DRAWINGS">FIGS. 9C-9E</figref> are schematic views of exemplary displays requesting information from the user relating to the patient.
0045<figref idref="DRAWINGS">FIG. 10</figref> is a schematic view of an exemplary subcutaneous for tube-fed patients process.
0046<figref idref="DRAWINGS">FIG. 11</figref> is a schematic view of an exemplary subcutaneous process without meal boluses.
0047<figref idref="DRAWINGS">FIGS. 12A and 12B</figref> are a schematic view of an exemplary meal-by-meal subcutaneous process without carbohydrate counting.
0048<figref idref="DRAWINGS">FIGS. 13A and 13B</figref> are a schematic view of an exemplary meal-by-meal subcutaneous process with carbohydrate counting.
0049<figref idref="DRAWINGS">FIGS. 14A and 14B</figref> are a schematic view of an exemplary subcutaneous non-diabetic process.
0050<figref idref="DRAWINGS">FIG. 15</figref> is a schematic view of an exemplary arrangement of operations for administering insulin.
0051<figref idref="DRAWINGS">FIG. 16</figref> is a schematic view of an exemplary arrangement of operations for administering insulin.
0052Like reference symbols in the various drawings indicate like elements.
DETAILED DESCRIPTION
0053Diabetic hospital patients who eat meals often have poor appetites; consequently, co-ordination of meal boluses and meals is difficult. Meal boluses without meals cause hypoglycemia; meals without meal boluses cause hyperglycemia. Different providers may use different methods of adjusting doses: some may use formulas of their own; some may use paper protocols that are complex and difficult for the nurse to follow, leading to a high incidence of human error; and some may use heuristic methods. There is no guarantee of consistency. Moreover, for diabetic patients who do not eat meals, there is no currently no computerized method of tracking the patient's status. For non-diabetic patient who get include due to “stress hyperglycemia” when they are very sick or undergoing surgery, there is no current method of monitoring their recovery when the stress subsides and their need for insulin rapidly decreases. If the dose regimen does not decrease rapidly also, hypoglycemia may result. Therefore, it is desirable to have a clinical support system <b>100</b> (<figref idref="DRAWINGS">FIGS. 1A and 1B</figref>) that monitors patients' blood glucose level.
0054Referring to <figref idref="DRAWINGS">FIG. 1A-1C</figref>, in some implementations, a clinical decision support system <b>100</b> analyzes inputted patient condition parameters for a patient <b>10</b> and calculates a personalized dose of insulin to bring and maintain the patient's blood glucose level into a target range BG<sub>TR</sub>. Moreover, the system <b>100</b> monitors the glucose levels of a patient <b>10</b> and calculates recommended intravenous or subcutaneous insulin dose to bring the patient's blood glucose into the preferred target range BG<sub>TR </sub>over a recommended period of time. A qualified and trained healthcare professional <b>40</b> may use the system <b>100</b> along with clinical reasoning to determine the proper dosing administered to a patient <b>10</b>. Therefore, the system <b>100</b> is a glycemic management tool for evaluation a patient's current and cumulative blood glucose value BG while taking into consideration the patient's information such as age, weight, and height. The system <b>100</b> may also consider other information such as carbohydrate content of meals, insulin doses being administered to the patient <b>10</b>, e.g., long-acting insulin doses for basal insulin and rapid-acting insulin doses for meal boluses and correction boluses. Based on those measurements (that may be stored in non-transitory memory <b>24</b>, <b>114</b>, <b>144</b>), the system <b>100</b> recommends an intravenous dosage of insulin, glucose, or saline or a subcutaneous basal and bolus insulin dosing recommendation or prescribed dose to adjust and maintain the blood glucose level towards a configurable (based on the patient's information) physician's determined blood glucose target range BG<sub>TR</sub>. The system <b>100</b> also considers a patient's insulin sensitivity or improved glycemic management and outcomes. The system <b>100</b> may take into account pertinent patient information such as demographics and previous results, leading to a more efficient use of healthcare resources. Finally, the system <b>100</b> provides a reporting platform for reporting the recommendations or prescribed dose(s) to the user <b>40</b> and the patient <b>10</b>. In addition, for diabetic patients who eat meals, the system <b>100</b> provides faster, more reliable, and more efficient insulin administration than a human monitoring the insulin administration. The system <b>100</b> reduces the probability of human error and insures consistent treatment, due to the system's capability of storing and tracking the patient's blood glucose levels BG, which may be used for statistical studies. As for patients who are tube-fed or do not eat meals, the system <b>100</b> provides dedicated subprograms, which in turn provide basal insulin and correction boluses but no meal boluses. Patients who are tube-fed or who do not eat usually have a higher basal insulin level than patients who eat, because the carbohydrates in the nutritive formula are accounted-for in the basal insulin. The system <b>100</b> provides a meal-by-meal adjustment of Meal Boluses without carbohydrate counting, by providing a dedicated subprogram that adjusts meal boluses based on the immediately preceding meal bolus and the BG that followed it. The system <b>100</b> provides a meal-by-meal adjustment of Meal Boluses with carbohydrate counting by providing a dedicated subprogram that adjusts meal boluses based a Carbohydrate-to-Insulin Ratio (CIR) that is adjusted at each meal, based on the CIR used at the immediately preceding meal bolus and the BG that followed it.
0055Hyperglycemia is a condition that exists when blood sugars are too high. While hyperglycemia is typically associated with diabetes, this condition can exist in many patients who do not have diabetes, yet have elevated blood sugar levels caused by trauma or stress from surgery and other complications from hospital procedures. Insulin therapy is used to bring blood sugar levels back into a normal range.
0056Hypoglycemia may occur at any time when a patient's blood glucose level is below a preferred target. Appropriate management of blood glucose levels for critically ill patients reduces co-morbidities and is associated with a decrease in infection rates, length of hospital stay, and death. The treatment of hyperglycemia may differ depending on whether or not a patient has been diagnosed with Type 1 diabetes mellitus, Type 2 diabetes mellitus, gestational diabetes mellitus, or non-diabetic stress hyperglycemia. The blood glucose target range BG<sub>TR </sub>is defined by a lower limit, i.e., a low target BG<sub>RTL </sub>and an upper limit, i.e., a high target BG<sub>TRH</sub>.
0057Stress-related hyperglycemia: Patients often get “stress hyperglycemia” if they are very sick or undergoing surgery. This condition requires insulin. In diabetic patients, the need for insulin is visibly increased. In non-diabetic patients, the stress accounts for the only need for insulin, and as the patients recover, the stress subsides, and their need for insulin rapidly decreases. For non-diabetic patients, the concern is that their need for insulin decreases faster than their dose regimen, leading to hypoglycemia.
0058Diabetes Mellitus has been treated for many years with insulin. Some recurring terms and phrases are described below:
0059Injection: Administering insulin by means of manual syringe or an insulin “pen,” with a portable syringe named for its resemblance to the familiar writing implement.
0060Infusion: Administering insulin in a continuous manner by means of an insulin pump for subcutaneous insulin or an intravenous apparatus <b>123</b><i>a</i>, both of which are capable of continuous administration.
0061Intravenous Insulin Therapy: Intravenous infusion of insulin has been approved by the U.S. Food and Drug Administration as an acceptable indication for use. Intravenous infusion is the fastest of all insulin administration routes and, typically, only available in the hospital setting. For instance, in intensive care units, the patients may be fed by intravenous glucose infusion, by intravenous Total Parenteral Nutrition (TPN), or by a tube to the stomach. Patients are often given insulin in an intravenous infusion at an insulin infusion rate IIR. The IIR is regulated by the frequent testing of blood glucose, typically at intervals between about 20 minutes and 2 hours. This is combined with a protocol in which a new IIR is computed after each blood glucose test.
0062Basal-Bolus Therapy: Basal-bolus therapy is a term that collectively refers to any insulin regimen involving basal insulin and boluses of insulin.
0063Basal Insulin: Insulin that is intended to metabolize the glucose released by a patient's the liver during a fasting state. Basal insulin is administered in such a way that it maintains a background level of insulin in the patient's blood, which is generally steady but may be varied in a programmed manner by an insulin pump <b>123</b><i>a</i>. Basal insulin is a slow, relatively continuous supply of insulin throughout the day and night that provides the low, but present, insulin concentration necessary to balance glucose consumption (glucose uptake and oxidation) and glucose production (glucogenolysis and gluconeogenesis). A patient's Basal insulin needs are usually about 10 to 15 mU/kg/hr and account for 30% to 50% of the total daily insulin needs; however, considerable variation occurs based on the patient <b>10</b>.
0064Bolus Insulin: Insulin that is administered in discrete doses. There are two main types of boluses, Meal Bolus and Correction Bolus.
0065Meal Bolus: Taken just before a meal in an amount which is proportional to the anticipated immediate effect of carbohydrates in the meal entering the blood directly from the digestive system. The amounts of the Meal Boluses may be determined and prescribed by a physician <b>40</b> for each meal during the day, i.e., breakfast, lunch, and dinner. Alternatively, the Meal Bolus may be calculated in an amount generally proportional to the number of grams of carbohydrates in the meal. The amount of the Meal Bolus is calculated using a proportionality constant, which is a personalized number called the Carbohydrate-to-Insulin Ratio (CIR) and calculated as follows: <br />Meal Insulin Bolus={grams of carbohydrates in the meal}/CIR (1)
0066Correction Bolus CB: Injected immediately after a blood glucose measurement; the amount of the correction bolus is proportional to the error in the BG (i.e., the bolus is proportional to the difference between the blood glucose measurement BG and the patient's personalized Target blood glucose BG<sub>Target</sub>). The proportionality constant is a personalized number called the Correction Factor, CF, and is calculated as follows: <br />CB=(BG−BG<sub>Target</sub>)/CF, (2)
0067A Correction Bolus CB is generally administered in a fasting state, after the previously consumed meal has been digested. This often coincides with the time just before the next meal.
0068There are several kinds of Basal-Bolus insulin therapy including Insulin Pump therapy and Multiple Dose Injection therapy:
0069Insulin Pump Therapy: An insulin pump <b>123</b><i>a </i>is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion therapy. The device includes: a pump, a disposable reservoir for insulin, and a disposable infusion set. The pump <b>123</b><i>a </i>is an alternative to multiple daily injections of insulin by insulin syringe or an insulin pen and allows for intensive insulin therapy when used in conjunction with blood glucose monitoring and carbohydrate counting. The insulin pump <b>123</b><i>a </i>is a battery-powered device about the size of a pager. It contains a cartridge of insulin, and it pumps the insulin into the patient via an “infusion set”, which is a small plastic needle or “canula” fitted with an adhesive patch. Only rapid-acting insulin is used.
0070Multiple Dose Injection (MDI): MDI involves the subcutaneous manual injection of insulin several times per day using syringes or insulin pens <b>123</b><i>b</i>. Meal insulin is supplied by injection of rapid-acting insulin before each meal in an amount proportional to the meal. Basal insulin is provided as a once, twice, or three time daily injection of a dose of long-acting insulin. Other dosage frequencies may be available. Advances continue to be made in developing different types of insulin, many of which are used to great advantage with MDI regimens:
0071Long-acting insulins are non-peaking and can be injected as infrequently as once per day. These insulins are widely used for Basal Insulin. They are administered in dosages that make them appropriate for the fasting state of the patient, in which the blood glucose is replenished by the liver to maintain a steady minimum blood glucose level.
0072Rapid-acting insulins act on a time scale shorter than natural insulin. They are appropriate for boluses.
0073In some examples, critically ill patients are ordered nil per os (NPO), which means that oral food and fluids are withheld from the patient <b>10</b>. Typically these patients <b>10</b> are unconscious, have just completed an invasive surgical procedure, or generally have difficulty swallowing. Intravenous insulin infusion is typically the most effective method of managing blood glucose levels in these patients. A patient <b>10</b> may be NPO and receiving a steady infusion of intravenous glucose, Total Parenteral Nutrition, tube feeding, regular meals that include carbohydrates, or not receiving any nutrition at all. In cases where the patient <b>10</b> is not receiving any nutrition, blood glucose is typically replaced by endogenous production by the liver.
0074As a patient's condition improves, an NPO order may be lifted, allowing the patient <b>10</b> to commence an oral caloric intake. In patients <b>10</b> with glycemic abnormalities, additional insulin may be needed to cover the consumption of carbohydrates. These patients <b>10</b> generally receive one-time injections of insulin in the patient's subcutaneous tissue.
0075Subcutaneous administration of mealtime insulin in critically ill patients <b>10</b> can introduce a patient safety risk if, after receiving the insulin injection, the patient <b>10</b> decides not to eat, is unable to finish the meal, or experiences emesis.
0076Continuous intravenous infusion of mealtime insulin, over a predetermined time interval, allows for an incremental fulfillment of the patient's mealtime insulin requirement, while minimizing patient safety risks. If a patient <b>10</b> decides he/she is unable to eat, the continuous intravenous infusion may be stopped or, if a patient <b>10</b> is unable to finish the meal, the continuous intravenous infusion rate may be decreased to compensate for the reduction in caloric intake.
0077The pharmacokinetics (what the body does to a drug over a period of time, which includes the processes of absorption, distribution, localization in tissues, biotransformation, and excretion) and pharmacodynamics (what a drug does to the body) actions of insulin significantly improve when administering insulin via an intravenous route, which is a typical method of delivery for hospitalized patients <b>10</b>. The management of prandial insulin requirements using an intravenous route can improve patient safety, insulin efficiency, and the accuracy of insulin dosing. The majority of patients who require continuous intravenous insulin infusion therapy may also need to be transitioned to a subcutaneous insulin regimen for ongoing control of blood glucose, regardless of diabetes mellitus (DM) diagnosis. Moreover, the timing, dosing, and process to transition patients <b>10</b> from a continuous intravenous route of insulin administration to a subcutaneous insulin regimen is complex and should be individualized based on various patient parameters. Failure to individualize this approach could increase the risk of severe hypoglycemia during the transition process. If not enough insulin is given, the patient <b>10</b> may experience acute post-transition hyperglycemia, requiring re-initiation of a continuous intravenous insulin infusion. Therefore, the clinical decision support system <b>100</b> calculates a personalized dose of insulin to bring and maintain the patient's blood glucose level into a target range BG<sub>TR</sub>, while taking into consideration the condition of the patient <b>10</b>.
0078The clinical decision support system <b>100</b> includes a glycemic management module <b>50</b>, an integration module <b>60</b>, a surveillance module <b>70</b>, and a reporting module <b>80</b>. Each module <b>50</b>, <b>60</b>, <b>70</b>, <b>80</b> is in communication with the other modules <b>50</b>, <b>60</b>, <b>70</b>, <b>80</b> via a network <b>20</b>. In some examples, the network <b>24</b> (discussed below) provides access to cloud computing resources that allows for the performance of services on remote devices instead of the specific modules <b>50</b>, <b>60</b>, <b>70</b>, <b>80</b>. The glycemic management module <b>50</b> executes a process <b>200</b> (e.g., an executable instruction set) on a processor <b>112</b>, <b>132</b>, <b>142</b> or on the cloud computing resources. The integration module <b>60</b> allows for the interaction of users <b>40</b> with the system <b>100</b>. The integration module <b>60</b> receives information inputted by a user <b>40</b> and allows the user <b>40</b> to retrieve previously inputted information stored on a storage system (e.g., one or more of cloud storage resources <b>24</b>, a non-transitory memory <b>144</b> of a hospital's electronic medical system <b>140</b>, a non-transitory memory <b>114</b> of the patient device <b>110</b>, or other non-transitory storage media in communication with the integration module <b>60</b>). Therefore, the integration module <b>60</b> allows for the interaction between the users <b>40</b> and the system <b>100</b> via a display <b>116</b>, <b>146</b>. The surveillance module <b>70</b> considers patient information <b>208</b><i>a </i>received from a user <b>40</b> via the integration module <b>60</b> and information received from a glucometer <b>124</b> that measures a patient's blood glucose value BG and determines if the patient <b>10</b> is within a threshold blood glucose value BG<sub>TH</sub>. In some examples, the surveillance module <b>70</b> alerts the user <b>40</b> if a patient's blood glucose values BG are not within a threshold blood glucose value BG<sub>TH</sub>. The surveillance module <b>70</b> may be preconfigured to alert the user <b>40</b> of other discrepancies between expected values and actual values based on pre-configured parameters (discussed below). For example, when a patient's blood glucose value BG drops below a lower limit of the threshold blood glucose value BG<sub>THL</sub>. The reporting module <b>80</b> may be in communication with at least one display <b>116</b>, <b>146</b> and provides information to the user <b>40</b> determined using the glycemic management module <b>50</b>, the integration module <b>60</b>, and/or the surveillance module <b>70</b>. In some examples, the reporting module <b>80</b> provides a report that may be displayed on a display <b>116</b>, <b>146</b> and/or is capable of being printed.
0079The system <b>100</b> is configured to evaluate a glucose level and nutritional intake of a patient <b>10</b>. The system <b>100</b> also evaluates whether the patient <b>10</b> is transitioning to a subcutaneous insulin regime. Based on the evaluation and analysis of the data, the system <b>100</b> calculates an insulin dose, which is administered to the patient <b>10</b> to bring and maintain the blood glucose level of the patient <b>10</b> into the blood glucose target range BG<sub>TR</sub>. The system <b>100</b> may be applied to various devices, including, but not limited to, intravenous infusion pumps <b>123</b><i>a</i>, subcutaneous insulin infusion pumps <b>123</b><i>a</i>, glucometers, continuous glucose monitoring systems, and glucose sensors. In some implementations, as the system <b>100</b> is monitoring the patient's blood glucose values BG and the patient's insulin intake, the system <b>100</b> notifies the user <b>40</b> if the patient <b>10</b> receives more than 500 units/hour of insulin because the system <b>100</b> considers these patients <b>10</b> to be insulin resistant.
0080In some examples the clinical decision support system <b>100</b> includes a network <b>20</b>, a patient device <b>110</b>, a dosing controller <b>160</b>, and a service provider <b>130</b>. The patient device <b>110</b> may include, but is not limited to, desktop computers or portable electronic device (e.g., cellular phone, smartphone, personal digital assistant, barcode reader, personal computer, or a wireless pad) or any other electronic device capable of sending and receiving information via the network <b>20</b>.
0081The patient device <b>110</b> includes a data processor <b>112</b> (e.g., a computing device that executes instructions), and non-transitory memory <b>114</b> and a display <b>116</b> (e.g., touch display or non-touch display) in communication with the data processor <b>112</b>. In some examples, the patient device <b>110</b> includes a keyboard <b>118</b>, speakers <b>120</b>, microphones, mouse, and a camera.
0082The service provider <b>130</b> may include a data processor <b>132</b> in communication with non-transitory memory <b>134</b>. The service provider <b>130</b> provides the patient <b>10</b> with a process <b>200</b> (see <figref idref="DRAWINGS">FIG. 2</figref>) (e.g., a mobile application, a web-site application, or a downloadable program that includes a set of instructions) executable on a processor <b>112</b>, <b>132</b>, <b>142</b> of the dosing controller <b>160</b> and accessible through the network <b>20</b> via the patient device <b>110</b>, intravenous infusion pumps <b>123</b><i>a</i>, hospital electronic medical record systems <b>140</b>, or portable blood glucose measurement devices <b>124</b> (e.g., glucose meter or glucometer). Intravenous infusion pumps infuse fluids, medication or nutrients into a patient's circulatory system. Intravenous infusion pumps <b>123</b><i>a </i>may be used intravenously and, in some instances, subcutaneous, arterial and epidural infusions are used. Intravenous infusion pumps <b>123</b><i>a </i>typically administer fluids that are expensive or unreliable if administered manually (e.g., using a pen <b>123</b><i>b</i>) by a nurse or doctor <b>40</b>. Intravenous infusion pumps <b>123</b><i>a </i>can administer a 0.1 ml per hour injection, injections every minute, injections with repeated boluses requested by the patient, up to a maximum number per hours, or fluids whose volumes vary by the time of day.
0083In some implementations, an electronic medical record system <b>140</b> is located at a hospital <b>42</b> (or a doctor's office) and includes a data processor <b>142</b>, a non-transitory memory <b>144</b>, and a display <b>146</b> (e.g., touch display or non-touch display). The transitory memory <b>144</b> and the display <b>146</b> are in communication with the data processor <b>142</b>. In some examples, the hospital electronic medical system <b>140</b> includes a keyboard <b>148</b> in communication with the data processor <b>142</b> to allow a user <b>40</b> to input data, such as patient information <b>208</b><i>a </i>(<figref idref="DRAWINGS">FIGS. 2A and 2B</figref>). The non-transitory memory <b>144</b> maintains patient records capable of being retrieved, viewed, and, in some examples, modified and updated by authorized hospital personal on the display <b>146</b>.
0084The dosing controller <b>160</b> is in communication with the glucometer <b>124</b> and includes a computing device <b>112</b>, <b>132</b>, <b>142</b> and non-transitory memory <b>114</b>, <b>134</b>, <b>144</b> in communication with the computing device <b>112</b>, <b>132</b>, <b>142</b>. The dosing controller <b>160</b> executes the process <b>200</b>. The dosing controller <b>160</b> stores patient related information retrieved from the glucometer <b>124</b> to determine an insulin dose rate IRR based on the received blood glucose measurement BG.
0085Referring to <figref idref="DRAWINGS">FIG. 1C</figref>, in some implementations, the insulin device <b>123</b> (e.g., administration device), in communication with the dosing controller <b>160</b>, capable of executing instructions for administering insulin according to a subcutaneous insulin treatment program selected by the dosing controller <b>160</b>. The administration device <b>123</b> may include the insulin pump <b>123</b><i>a </i>or the pen <b>123</b><i>b</i>. The administration device <b>123</b> is in communication with the glucometer <b>124</b> and includes a computing device <b>112</b><i>a</i>, <b>112</b><i>b </i>and non-transitory memory <b>114</b><i>a</i>, <b>114</b><i>b </i>in communication with the computing device <b>112</b><i>a</i>, <b>112</b><i>b</i>. The administration device <b>123</b> includes a doser <b>223</b><i>a</i>, <b>223</b><i>b </i>in communication with the administration computing device <b>112</b><i>a</i>, <b>112</b><i>b </i>for administering insulin to the patient. For instance, the doser <b>223</b><i>a </i>of the insulin pump <b>123</b><i>a </i>includes an infusion set including a tube in fluid communication with an insulin reservoir and a cannula inserted into the patient's <b>10</b> body and secured via an adhesive patch. The doser <b>223</b><i>b </i>of the pen <b>123</b><i>b </i>includes a needle for insertion into the patient's <b>10</b> body for administering insulin from an insulin cartridge. The administration device <b>123</b> may receive a subcutaneous insulin treatment program selected by and transmitted from the dosing controller <b>160</b>, while the administration computing device <b>112</b><i>a</i>, <b>112</b><i>b </i>may execute the subcutaneous insulin treatment program. Executing the subcutaneous insulin treatment program by the administration computing device <b>112</b><i>a</i>, <b>112</b><i>b </i>causes the doser <b>223</b><i>a</i>, <b>223</b><i>b </i>to administer doses of insulin specified by the subcutaneous insulin treatment program. For instance, units for the doses of insulin may be automatically set or dialed in by the administration device <b>123</b><i>a</i>, <b>123</b><i>b </i>and administered via the doser <b>223</b><i>a</i>, <b>223</b><i>b </i>to the patient <b>10</b>.
0086The network <b>20</b> may include any type of network that allows sending and receiving communication signals, such as a wireless telecommunication network, a cellular telephone network, a time division multiple access (TDMA) network, a code division multiple access (CDMA) network, Global system for mobile communications (GSM), a third generation (3G) network, fourth generation (4G) network, a satellite communications network, and other communication networks. The network <b>20</b> may include one or more of a Wide Area Network (WAN), a Local Area Network (LAN), and a Personal Area Network (PAN). In some examples, the network <b>20</b> includes a combination of data networks, telecommunication networks, and a combination of data and telecommunication networks. The patient device <b>110</b>, the service provider <b>130</b>, and the hospital electronic medical record system <b>140</b> communicate with each other by sending and receiving signals (wired or wireless) via the network <b>20</b>. In some examples, the network <b>20</b> provides access to cloud computing resources, which may be elastic/on-demand computing and/or storage resources <b>24</b> available over the network <b>20</b>. The term ‘cloud’ services generally refers to a service performed not locally on a user's device, but rather delivered from one or more remote devices accessible via one or more networks <b>20</b>.
0087Referring to <figref idref="DRAWINGS">FIGS. 1B and 2A-2C</figref>, the process <b>200</b> receives parameters (e.g., patient condition parameters) inputted via the client device <b>110</b>, the service provider <b>130</b>, and/or the hospital system <b>140</b>, analyzes the inputted parameters, and determines a personalized dose of insulin to bring and maintain a patient's blood glucose level BG into a preferred target range BG<sub>TR</sub>.
0088In some implementations, before the process <b>200</b> begins to receive the parameters, the process <b>200</b> may receive a username and a password (e.g., at a login screen displayed on the display <b>116</b>, <b>146</b>) to verify that a qualified and trained healthcare professional <b>40</b> is initiating the process <b>200</b> and entering the correct information that the process <b>200</b> needs to accurately administer insulin to the patient <b>10</b>. The system <b>100</b> may customize the login screen to allow a user <b>40</b> to reset their password and/or username. Moreover, the system <b>100</b> may provide a logout button (not shown) that allows the user <b>40</b> to log out of the system <b>100</b>. The logout button may be displayed on the display <b>116</b>, <b>146</b> at any time during the execution of the process <b>200</b>.
0089The clinical decision support system <b>100</b> may include an alarm system <b>120</b> that alerts a user <b>40</b> when the patient's blood glucose level BG is outside the target range BG<sub>TR</sub>. The alarm system <b>120</b> may produce an audible sound via speaker <b>122</b> in the form of a beep or some like audio sounding mechanism. In some examples, the alarm system <b>120</b> displays a warning message or other type of indication on the display <b>116</b> of the patient device <b>110</b> to provide a warning message. The alarm system <b>120</b> may also send the audible and/or visual notification via the network <b>20</b> to the hospital system <b>140</b> (or any other remote station) for display on the display <b>146</b> of the hospital system <b>140</b> or played through speakers <b>152</b> of the hospital system <b>140</b>.
0090The process <b>200</b> prompts a user <b>40</b> to input patient information <b>208</b><i>a </i>at block <b>208</b>. The user <b>40</b> may input the patient information <b>208</b><i>a</i>, for example, via the user device <b>110</b> or via the hospital electronic medical record systems <b>140</b> located at a hospital <b>42</b> (or a doctor's office). The user <b>40</b> may input new patient information <b>208</b><i>a </i>as shown in <figref idref="DRAWINGS">FIG. 2B</figref> or retrieve previously stored patient information <b>208</b><i>a </i>as shown in <figref idref="DRAWINGS">FIG. 2C</figref>. In some implementations, the process <b>200</b> provides the user <b>40</b> with a patient list <b>209</b> (<figref idref="DRAWINGS">FIG. 2C</figref>) where the user <b>40</b> selects one of the patient names from the patient list <b>209</b>, and the process <b>200</b> retrieves that patient's information <b>208</b><i>a</i>. The process <b>200</b> may allow the user <b>40</b> to filer the patient list <b>209</b>, e.g., alphabetically (first name or last name), by location, patient identification. The process <b>200</b> may retrieve the patient information <b>208</b><i>a </i>from the non-transitory memory <b>144</b> of the hospital's electronic medical system <b>140</b> or the non-transitory memory <b>114</b> of the patient device <b>110</b> (e.g., where the patient information <b>208</b><i>a </i>was previously entered and stored). The patient information <b>208</b><i>a </i>may include, but is not limited to, a patient's name, a patient's identification number (ID), a patient's height, weight, date of birth, diabetes history, physician name, emergency contact, hospital unit, diagnosis, gender, room number, and any other relevant information. In some examples, the diagnosis may include, but is not limited to, burn patients, Coronary artery bypass patients, stoke patients, diabetic ketoacidosis (DKA) patients, and trauma patients. After the user <b>40</b> completes inputting the patient information <b>208</b><i>a</i>, the process <b>200</b> at block <b>202</b> determines whether the patient <b>10</b> is being treated with an intravenous treatment module by prompting the user <b>40</b> (e.g., on the display <b>116</b>, <b>146</b>) to input whether the patient <b>10</b> will be treated with an intravenous treatment module. If the patient <b>10</b> will not be treated with the intravenous treatment module, the process <b>200</b> determines at block <b>210</b> whether the patient <b>10</b> will be treated with a subcutaneous treatment module, by asking the user <b>40</b> (e.g., by prompting the user <b>40</b> on the display <b>116</b>, <b>146</b>). If the user <b>40</b> indicates that the patient <b>10</b> will be treated with the subcutaneous treatment, the process <b>200</b> flows to block <b>216</b>, where the user <b>40</b> enters patient subcutaneous information <b>216</b><i>a</i>, such as bolus insulin type, target range, basal insulin type and frequency of distribution (e.g., 1 dose per day, 2 doses per day, 3 doses per day, etc.), patient diabetes status, subcutaneous type ordered for the patient (e.g., Basal/Bolus and correction that is intended for patients on a consistent carbohydrate diet, or Basal and correction that is intended for patients who are NPO or on continuous enteral feeds), frequency of patient blood glucose measurements, or any other relevant information. In some implementations, the patient subcutaneous information <b>216</b><i>a </i>is prepopulated with default parameters, which may be adjusted or modified. When the user <b>40</b> enters the patient subcutaneous information <b>216</b>, the subcutaneous program begins at block <b>226</b>. The process may determine whether the patient <b>10</b> is being treated with an intravenous treatment or a subcutaneous treatment by prompting the user <b>40</b> to select between two options (e.g., a button displayed on the display <b>116</b>, <b>146</b>), one being the intravenous treatment and the other begin the subcutaneous treatment. In some implementations, the subcutaneous program (at block <b>226</b>) includes six sub programs: a subcutaneous standard program (<figref idref="DRAWINGS">FIGS. 9A-9B</figref>); a subcutaneous for tube-fed patients program (<figref idref="DRAWINGS">FIG. 10</figref>); a subcutaneous program without meal boluses (<figref idref="DRAWINGS">FIG. 11</figref>); a meal-by-meal subcutaneous program without carbohydrate counting (<figref idref="DRAWINGS">FIG. 12</figref>); a meal-by-meal subcutaneous program with carbohydrate counting (<figref idref="DRAWINGS">FIGS. 13A-13B</figref>); and a subcutaneous program for non-diabetic patients (<figref idref="DRAWINGS">FIG. 14</figref>).
0091In some implementations and referring back to block <b>202</b>, if the process <b>200</b> determines that the patient <b>10</b> will be treated with the intravenous treatment module, the process <b>200</b> prompts the user <b>40</b> at block <b>204</b> for setup data <b>204</b><i>a</i>, such as patient parameters <b>204</b><i>a </i>relevant to the intravenous treatment mode. In some examples, the patient parameter <b>204</b><i>a </i>relating to the intravenous treatment may be prepopulated, for example, with default values that may be adjusted and modified by the user <b>40</b>. These patient parameters <b>204</b><i>a </i>may include an insulin concentration (i.e., the strength of insulin being used for the intravenous dosing, which may be measured in units/milliliter), the type of insulin and rate being administered to the patient, the blood glucose target range BG<sub>TR</sub>, the patient's diabetes history, a number of carbohydrates per meal, or any other relevant information. In some implementations, the type of insulin and the rate of insulin depend on the BG of the patient <b>10</b>. For example, the rate and type of insulin administered to a patient <b>10</b> when the blood glucose value BG of the patient <b>10</b> is greater or equal to 250 mgl/dl may be different than the rate and type of insulin administered to the patient <b>10</b> when the blood glucose value BG of the patient is greater than 250 ml/dl. The blood glucose target range BG<sub>TR </sub>may be a configurable parameter, customized based on various patient factors. The blood glucose target range BG<sub>TR </sub>may be limited to 40 mg/dl (e.g., 100-140 mg/dl, 140-180 mg/dl, and 120-160 mg/dl).
0092After the user <b>40</b> inputs patient parameters <b>204</b><i>a </i>for the intravenous treatment at block <b>204</b>, the process <b>200</b> prompts the user <b>40</b> to input the blood glucose value BG of the patient <b>10</b> at block <b>206</b>. The blood glucose value BG may be manually inputted by the user <b>40</b>, sent via the network <b>20</b> from a glucometer <b>124</b>, sent electronically from the hospital information or laboratory system <b>140</b>, or other wireless device. The process <b>200</b> determines a personalized insulin dose rate, referred to as an insulin infusion rate IIR, using the blood glucose value BG of the patient <b>10</b> and a dose calculation process <b>300</b>.
0093<figref idref="DRAWINGS">FIG. 3</figref> provides a dose calculation process <b>300</b> for calculating the insulin infusion rate IIR of the patient <b>10</b> for intravenous treatment after the process <b>200</b> receives the patient information <b>208</b><i>a </i>discussed above (including the patients' blood glucose value BG). At block <b>301</b> the dose calculation process <b>300</b> determines if the patient's blood glucose BG is less than a stop threshold value BG<sub>THstop</sub>. If not, then at block <b>303</b> the dose calculation process <b>300</b> goes to block <b>304</b> without taking any action. If, however, the patient's blood glucose BG is less than a stop threshold value BG<sub>THstop</sub>, then the calculation dose process sets the patient's regular insulin dose rate IRR to zero at block <b>302</b>, which then goes to block <b>322</b>. The dose calculation process <b>300</b> determines at decision block <b>304</b> if the inputted blood glucose value BG is the first inputted blood glucose value.
0094The patient's regular insulin dose rate IIR is calculated at block <b>320</b> in accordance with the following equation: <br />IIR=(BG−<i>K</i>)*<i>M</i> (3A)<br /> where K is a constant, known as the Offset Target, with the same unit of measure as blood glucose and M is a unit-less multiplier. In some examples, the Offset Target K is lower than the blood glucose target range of the patient <b>10</b>. The Offset Target K allows the dose calculation process <b>300</b> to calculate a non-zero stable insulin dose rate even with a blood glucose result is in the blood glucose target range BG<sub>TR</sub>.
0095The initial multiplier M<sub>I</sub>, determined by the physician <b>40</b>, approximates the sensitivity of a patient <b>10</b> to insulin. For example, the initial multiplier equals 0.02 for adults ages 18 and above. In some examples, the initial multiplier M<sub>I </sub>equals 0.01 for frail elderly patients <b>10</b> who may be at risk for complications arising when their blood glucose level BG falls faster than 80 mg/dl/hr. Moreover, the physician <b>40</b> may order a higher initial multiplier M<sub>I </sub>for patients <b>10</b> with special needs, such as CABG patients (i.e., patients who have undergone coronary artery bypass grafting) with BMI (Body Mass Index which is a measure for the human body shape based on the individual's mass and height) less than 30 might typically receive an initial multiplier of 0.05, whereas a patient <b>10</b> with BMI greater than 30 might receive an initial multiplier M<sub>I </sub>of 0.06. In addition, a patient's weight may be considered in determining the value of the initial multiplier M<sub>I</sub>, for examples, in pediatric treatments, the system <b>100</b> calculates a patient's initial multiplier M<sub>I </sub>using the following equation: <br /><i>M</i><sub>I</sub>=0.0002×Weight of patient (in kilograms) (3B)<br /> In some implementations, K is equal to 60 mg/dl. The dose calculation process <b>300</b> determines the target blood glucose target range BG<sub>TR </sub>using two limits inputted by the user <b>40</b>, a lower limit of the target range BG<sub>TRL </sub>and an upper (high) limit of the target range BG<sub>TRH</sub>. These limits are chosen by the user <b>40</b> so that they contain the desired blood glucose target as the midpoint. Additionally, the Offset Target K may be calculated dynamically in accordance with the following equation: <br /><i>K</i>=BG<sub>Target</sub>−Offset, (4)<br /> where BG<sub>Target </sub>is the midpoint of the blood glucose target range BG<sub>TR </sub>and Offset is the preconfigured distance between the target center BG<sub>Target </sub>and the Offset Target, K.
0096In some implementations, the insulin dose rate IRR may be determined by the following process on a processor <b>112</b>, <b>132</b>, <b>142</b>. Other processes may also be used.
0097<tables id="TABLE-US-00001" num="00001"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><thead><row><entry /><entry namest="offset" nameend="1" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /><entry>function IIR($sf, $current_bg, $bg_default = 60,</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>$insulin_concentration, $ins_units_of_measure = ‘units/hr’) {</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>settype($sf,‘float’);</entry></row><row><entry /><entry>settype($bg_default,‘float’);</entry></row><row><entry /><entry>settype($current_bg,‘float’);</entry></row><row><entry /><entry>settype($insulin_concentration,‘float’);</entry></row><row><entry /><entry>/*</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>@param $sf = sensitivity factor from db</entry></row><row><entry /><entry>@param $current_bg = the current bg value being</entry></row><row><entry /><entry>submitted</entry></row><row><entry /><entry>@param $db_default = the default “Stop Insulin When”</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>value....If it isn’t passed, it defaults to 60</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>@param $insulin_concentration = the default insulin</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>concentration from settings</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>*/</entry></row><row><entry /><entry>if($current_bg > 60) {</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>$iir = array( );</entry></row><row><entry /><entry>$iir[0] = round(($current_bg − $bg_default) * $sf, 1);</entry></row><row><entry /><entry>if ($ins_units_of_measure != ‘units/hr’) {</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="56pt" align="left" /><colspec colname="1" colwidth="161pt" align="left" /><tbody valign="top"><row><entry /><entry>$iir[1] = round(($current_bg − $bg_default) * $sf /</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>$insulin_concentration ,1);</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row><row><entry /><entry>return $iir;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>} else {</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>return 0;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row><row><entry /><entry namest="offset" nameend="1" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0098Referring to decision block <b>304</b>, when the dose calculation process <b>300</b> determines that the inputted blood glucose value BG is the first inputted blood glucose value, then the dose calculation process <b>300</b> defines the value of the current multiplier M equal to an initial multiplier (M<sub>I</sub>) at block <b>306</b>. The dose calculation process <b>300</b> then calculates, at block <b>320</b>, the Insulin Infusion Rate in accordance with the IIR equation (EQ. 3A) and returns to the process <b>200</b> (see <figref idref="DRAWINGS">FIG. 2</figref>).
0099However, referring back to decision block <b>304</b>, when the dose calculation process <b>300</b> determines that the inputted blood glucose value BG is not the first inputted blood glucose value, the dose calculation process <b>300</b> determines if the Meal Bolus Module has been activated at decision block <b>308</b>. If the dose calculation process <b>300</b> determines that the Meal Bolus Module has been activated, then the dose calculation process <b>300</b> begins a Meal Bolus process <b>500</b> (see <figref idref="DRAWINGS">FIG. 5</figref>).
0100Referring back to decision block <b>308</b>, if the Meal Bolus Module has not been activated, the dose calculation process <b>300</b> determines, at decision block <b>310</b>, if the current blood glucose value BG is greater than the upper limit BG<sub>TRH </sub>of the blood glucose target range BG<sub>TR</sub>. If the blood glucose value BG is greater than the upper limit BG<sub>TRH </sub>of the blood glucose target range BG<sub>TR</sub>, the dose calculation process <b>300</b> determines, at block <b>314</b>, a ratio of the current blood glucose value BG to the previous blood glucose value BG<sub>P</sub>, where BG<sub>P </sub>was measured at an earlier time than the current BG. The process <b>200</b> then determines if the ratio of the blood glucose to the previous blood glucose, BG/BG<sub>P</sub>, is greater than a threshold value L<sub>A</sub>, as shown in the following equation: <br />(BG/BG<sub>P</sub>)><i>L</i><sub>A</sub> (5)<br /> where BG is the patient's current blood glucose value; BG<sub>P </sub>is the patient's previous blood glucose value; and L<sub>A </sub>is the threshold ratio of BG/BG<sub>p </sub>for blood glucose values above the upper limit of the blood glucose target range BG<sub>TRH</sub>. If the ratio BG/BG<sub>p </sub>exceeds the threshold ratio L<sub>A</sub>, then the Multiplier M is increased. In some examples, the threshold ratio L<sub>A </sub>equals 0.85.
0101If the dose calculation process <b>300</b> determines that the ratio (BG/BG<sub>p</sub>) of the blood glucose value BG to the previous blood glucose value BG<sub>p </sub>is not greater than the threshold ratio L<sub>A </sub>for a blood glucose value BG above the upper limit BG<sub>TRH </sub>of the blood glucose target range BG<sub>TR</sub>, then the dose calculation process <b>300</b> sets the value of the current multiplier M to equal the value of the previous multiplier M<sub>P</sub>, see block <b>312</b>. <br /><i>M=M</i><sub>P</sub> (6)
0102Referring back to block <b>314</b>, if the dose calculation process <b>300</b> determines that the ratio (BG/BG<sub>p</sub>) of the blood glucose value BG to the previous blood glucose BG<sub>P </sub>is greater than the threshold ratio L<sub>A </sub>for a blood glucose value above upper limit BG<sub>TRH </sub>of the blood glucose target range BG<sub>TR</sub>, then dose calculation process <b>300</b> multiplies the value of the current multiplier M by a desired Multiplier Change Factor (M<sub>CF</sub>) at block <b>318</b>. The dose calculation process <b>300</b> then calculates the insulin infusion rate at block <b>320</b> using the IIR equation (EQ. 3A) and returns to the process <b>200</b> (see <figref idref="DRAWINGS">FIG. 2</figref>).
0103Referring back to block <b>310</b>, when the dose calculation process <b>300</b> determines that the current blood glucose value BG is not greater than the upper limit BG<sub>TRH </sub>of the blood glucose target range BG<sub>TR</sub>, the dose calculation process <b>300</b> then determines if the current blood glucose concentration BG is below the lower limit BG<sub>TRL</sub>, of the blood glucose target range BG<sub>TR </sub>at decision block <b>311</b>. If the current blood glucose value BG is below the lower limit BG<sub>TRL</sub>, of the blood glucose target range BG<sub>TR</sub>, the dose calculation process <b>300</b> at block <b>316</b> divides the value of the current multiplier M by the Multiplier Change Factor (M<sub>CF</sub>), in accordance with the following equation: <br /><i>M=M</i><sub>P</sub><i>/M</i><sub>CF</sub> (7)<br /> and calculates the current insulin infusion rate IIR using equation 3 at block <b>320</b> and returns to the process <b>200</b> (see <figref idref="DRAWINGS">FIG. 2</figref>).
0104At block <b>311</b>, if the dose calculation process <b>300</b> determines that the blood glucose value BG is not below the lower limit of the blood glucose target range BG<sub>TRL</sub>, the dose calculation process <b>300</b> sets the value of the current multiplier to be equal to the value of the previous multiplier M<sub>P </sub>at block <b>312</b> (see EQ. 6).
0105Referring again to <figref idref="DRAWINGS">FIG. 3</figref>, at block <b>311</b>, if the current blood glucose value BG is below the lower limit of the target range BG<sub>TRL</sub>, logic passes to decision block <b>322</b>, where the process <b>300</b> determines if the current blood glucose concentration BG is below a hypoglycemia threshold BG<sub>Hypo</sub>. If the current blood glucose BG is below the hypoglycemia threshold BG<sub>Hypo</sub>, logic then passes to block <b>324</b>, where the process <b>300</b> recommends hypoglycemia treatment, either by a calculation of an individualized dose of intravenous glucose or oral hypoglycemia treatment.
0106Referring back to <figref idref="DRAWINGS">FIG. 2A</figref>, after the dose calculation process <b>300</b> calculates the insulin infusion rate IIR, the process <b>200</b> proceeds to a time calculation process <b>400</b> (<figref idref="DRAWINGS">FIG. 4A</figref>) for calculating a time interval T<sub>Next </sub>until the next blood glucose measurement.
0107<figref idref="DRAWINGS">FIG. 4A</figref> shows the process <b>400</b> for calculating a time interval T<sub>Next </sub>between the current blood glucose measurement BG and the next blood glucose measurement BG<sub>next</sub>. The time-duration of blood glucose measurement intervals T<sub>Next </sub>may vary and the starting time interval can either be inputted by a user <b>40</b> at the beginning of the process <b>200</b>, <b>300</b>, <b>400</b>, or defaulted to a predetermined time interval, T<sub>Default </sub>(e.g., one hour). The time interval T<sub>Next </sub>is shortened if the blood glucose concentration BG of the patient <b>10</b> is decreasing excessively, or it may be lengthened if the blood glucose concentration BG of the patient <b>10</b> becomes stable within the blood glucose target range BG<sub>TR</sub>.
0108The process <b>400</b> determines a value for the time interval T<sub>Next </sub>based on several conditions. The process <b>400</b> checks for the applicability of several conditions, where each condition has a value for T<sub>next </sub>that is triggered by a logic-test (except T<sub>default</sub>). The process <b>400</b> selects the lowest value of T<sub>next </sub>from the values triggered by logic tests (not counting T<sub>default</sub>). If no logic test was triggered, the process selects T<sub>default</sub>. This is accomplished in <figref idref="DRAWINGS">FIG. 4A</figref> by the logic structure that selects the lowest values of T<sub>next </sub>first. However, other logic structures are possible as well.
0109The time calculation process <b>400</b> determines at decision block <b>416</b> if the current blood glucose BG is below the lower limit BG<sub>TRL </sub>(target range low limit) of the blood glucose target range BG<sub>TR</sub>. If the current blood glucose BG is below the lower limit BG<sub>TRL </sub>of the blood glucose target range BG<sub>TR</sub>, then the time calculation process <b>400</b> determines, at decision block <b>418</b>, if the current blood glucose BG is less than a hypoglycemia-threshold blood glucose level BG<sub>Hypo</sub>.
0110If the current blood glucose BG is less than the hypoglycemia-threshold blood glucose level BG<sub>Hypo </sub>the time calculation process <b>400</b> sets the time interval T<sub>Next </sub>to a hypoglycemia time interval T<sub>Hypo</sub>, e.g., 15 or 30 minutes, at block <b>426</b>. Then the time calculation process <b>400</b> is complete and returns to the process <b>200</b> (<figref idref="DRAWINGS">FIG. 2</figref>) at block <b>428</b>.
0111If the current blood glucose BG is not less than (i.e., is greater than) the hypoglycemia-threshold blood glucose level BG<sub>Hypo </sub>at block <b>418</b>, the time calculation process <b>400</b> determines at block <b>422</b> if the most recent glucose percent drop BG<sub>% Drop</sub>, is greater than the threshold glucose percentage drop % Drop<sub>Low Limit </sub>(for a low BG range) using the following equation:
0112<maths id="MATH-US-00001" num="00001"><math overflow="scroll"><mtable><mtr><mtd><mrow><mrow><msub><mi>BG</mi><mrow><mi>%</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><mi>drop</mi></mrow></msub><mo>></mo><mrow><mi>%</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><msub><mi>Drop</mi><mrow><mi>Low</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><mi>Limit</mi></mrow></msub></mrow></mrow><mo></mo><mstyle><mtext></mtext></mstyle><mo></mo><mi>since</mi></mrow></mtd><mtd><mrow><mo>(</mo><mrow><mn>8</mn><mo></mo><mi>A</mi></mrow><mo>)</mo></mrow></mtd></mtr><mtr><mtd><mrow><mrow><msub><mi>BG</mi><mrow><mi>%</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><mi>drop</mi></mrow></msub><mo>=</mo><mrow><mo>(</mo><mfrac><mrow><mo>(</mo><mrow><msub><mi>BG</mi><mi>P</mi></msub><mo>-</mo><mi>BG</mi></mrow><mo>)</mo></mrow><msub><mi>BG</mi><mi>P</mi></msub></mfrac><mo>)</mo></mrow></mrow><mo></mo><mstyle><mtext></mtext></mstyle><mo></mo><mrow><mi>then</mi><mo>,</mo></mrow></mrow></mtd><mtd><mrow><mo>(</mo><mrow><mn>8</mn><mo></mo><mi>B</mi></mrow><mo>)</mo></mrow></mtd></mtr><mtr><mtd><mrow><mrow><mo>(</mo><mfrac><mrow><mo>(</mo><mrow><msub><mi>BG</mi><mi>P</mi></msub><mo>-</mo><mi>BG</mi></mrow><mo>)</mo></mrow><msub><mi>BG</mi><mi>P</mi></msub></mfrac><mo>)</mo></mrow><mo>></mo><mrow><mi>%</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><msub><mi>Drop</mi><mrow><mi>Low</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><mi>Limit</mi></mrow></msub></mrow></mrow></mtd><mtd><mrow><mo>(</mo><mrow><mn>8</mn><mo></mo><mi>C</mi></mrow><mo>)</mo></mrow></mtd></mtr></mtable></math></maths><img file="US10255992B2_D0001.tif" /><br /> where BG<sub>P </sub>is a previously measured blood glucose.
0113If the current glucose percent drop BG<sub>% Drop</sub>, is not greater than the limit for glucose percent drop (for the low BG range) % Drop<sub>Low Limit</sub>, the time calculation process <b>400</b> passes the logic to block <b>412</b>. In some examples, the low limit % Drop<sub>Low Limit </sub>equals 25%.
0114Referring back to block <b>422</b>, if the current glucose percent drop BG<sub>% Drop </sub>is greater than the limit for glucose percent drop (for the low BG range) % Drop<sub>Low Limit</sub>, the time calculation process <b>400</b> at block <b>424</b> sets the time interval to a shortened time interval T<sub>Short</sub>, for example 20 minutes, to accommodate for the increased drop rate of the blood glucose BG. Then the time calculation process <b>400</b> is complete and returns to the process <b>200</b> (<figref idref="DRAWINGS">FIG. 2</figref>) at block <b>428</b>.
0115Referring back to decision block <b>416</b>, if the time calculation process <b>400</b> determines that the current blood glucose BG is not below the lower limit BG<sub>TRL </sub>for the blood glucose target range BG<sub>TR</sub>, the time calculation process <b>400</b> determines at block <b>420</b> if the blood glucose BG has decreased by a percent of the previous blood glucose that exceeds a limit % Drop<sub>Regular </sub>(for the regular range, i.e., blood glucose value BG>BG<sub>TRL</sub>), using the formula:
0116<maths id="MATH-US-00002" num="00002"><math overflow="scroll"><mtable><mtr><mtd><mrow><mrow><mo>(</mo><mfrac><mrow><mo>(</mo><mrow><msub><mi>BG</mi><mi>P</mi></msub><mo>-</mo><mi>BG</mi></mrow><mo>)</mo></mrow><msub><mi>BG</mi><mi>P</mi></msub></mfrac><mo>)</mo></mrow><mo>></mo><mrow><mi>%</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><msub><mi>Drop</mi><mi>Regular</mi></msub></mrow></mrow></mtd><mtd><mrow><mo>(</mo><mn>9</mn><mo>)</mo></mrow></mtd></mtr></mtable></math></maths><img file="US10255992B2_D0002.tif" />
0117If the blood glucose BG has decreased by a percentage that exceeds the regular threshold glucose percent drop (for the regular BG range) % Drop<sub>Regular</sub>, the time calculation process <b>400</b>, at block <b>425</b>, sets the time interval to the shortened time interval T<sub>Short</sub>, for example 20 minutes. A reasonable value for % Drop<sub>Regular </sub>for many implementations is 66%. Then the time calculation process <b>400</b> is complete and returns to the process <b>200</b> (<figref idref="DRAWINGS">FIG. 2</figref>) at block <b>428</b>. If, however, the glucose has not decreased by a percent that exceeds the threshold glucose percent drop % Drop<sub>Regular</sub>, (for the regular BG range), the time calculation process <b>400</b> routes the logic to block <b>412</b>. The process <b>400</b> determines, at block <b>412</b>, a blood glucose rate of descent BG<sub>DropRate </sub>based on the following equation: <br />BG<sub>DropRate</sub>=(BG<sub>P</sub>−BG)/(<i>T</i><sub>Current</sub><i>−T</i><sub>Previous</sub>) (10)<br /> where BG<sub>P </sub>is the previous blood glucose measurement, T<sub>Current </sub>is the current time and T<sub>Previous </sub>is the previous time. Moreover, the process <b>400</b> at block <b>412</b> determines if the blood glucose rate of descent BG<sub>DropRate </sub>is greater than a preconfigured drop rate limit BG<sub>dropRateLimit</sub>.
0118If the time calculation process <b>400</b> at block <b>412</b> determines that the blood glucose rate of descent BG<sub>DropRate</sub>, has exceeded the preconfigured drop rate limit BG<sub>dropRateLimit</sub>, the time interval T<sub>Next </sub>until the next blood glucose measurement is shortened at block <b>414</b> to a glucose drop rate time interval T<sub>BGDR</sub>, which is a relatively shorter time interval than the current time interval T<sub>Current</sub>, as consideration for the fast drop. The preconfigured drop rate limit BG<sub>dropRateLimit </sub>may be about 100 mg/dl/hr. The glucose drop rate time interval T<sub>BGDR </sub>may be 30 minutes, or any other predetermined time. In some examples, a reasonable value for T<sub>Default </sub>is one hour. Then the time calculation process <b>400</b> is complete and returns to the process <b>200</b> (<figref idref="DRAWINGS">FIG. 2</figref>) at block <b>428</b>.
0119If the time calculation process <b>400</b> determines at block <b>412</b> that the glucose drop rate BG<sub>DropRate </sub>does not exceed the preconfigured rate limit BG<sub>dropRateLimit</sub>, the time calculation process <b>400</b> determines, at block <b>408</b>, if the patient's blood glucose concentration BG has been within the desired target range BG<sub>TR </sub>(e.g., BG<sub>TRL</sub><BG<BG<sub>TRH</sub>) for a period of time T<sub>Stable</sub>. The criterion for stability in the blood glucose target range BG<sub>TR </sub>is a specified time in the target range BG<sub>TR </sub>or a specified number of consecutive blood glucose measurements in the target range BG<sub>TR</sub>. For example, the stable period of time T<sub>Stable </sub>may be one hour, two hours, two and a half hours, or up to 4 hours. If the stability criterion is met then the time interval T<sub>Next </sub>until the next scheduled blood glucose measurement BG may be set at block <b>410</b> to a lengthened time interval T<sub>Long </sub>(such as 2 hours) that is generally greater than the default time interval T<sub>Default</sub>. Then the time calculation process <b>400</b> is complete and returns to the process <b>200</b> (<figref idref="DRAWINGS">FIG. 2</figref>) at block <b>428</b>. If the time calculation process <b>400</b> determines that the patient <b>10</b> has not met the criteria for stability, the time calculation process <b>400</b> sets the time interval T<sub>Next </sub>to a default time interval T<sub>Default </sub>at block <b>406</b>. Then the time calculation process <b>400</b> is complete and returns to the process <b>200</b> (<figref idref="DRAWINGS">FIG. 2</figref>) at block <b>428</b>.
0120Referring to <figref idref="DRAWINGS">FIGS. 4B and 4C</figref>, once the time calculation process <b>400</b> calculates the recommended time interval T<sub>Next</sub>, the process <b>200</b> provides a countdown timer <b>430</b> that alerts the user <b>40</b> when the next blood glucose measurement is due. The countdown timer <b>430</b> may be on the display <b>116</b> of the patient device <b>110</b> or displayed on the display <b>146</b> of the hospital system <b>140</b>. When the timer <b>430</b> is complete, a “BG Due!” message might be displayed as shown in <figref idref="DRAWINGS">FIG. 4B</figref>. The countdown timer <b>430</b> may include an overdue time <b>432</b> indicating the time late if a blood glucose value is not entered as scheduled.
0121In some implementations, the countdown timer <b>430</b> connects to the alarm system <b>120</b> of the user device <b>110</b>. The alarm system <b>120</b> may produce an audible sound via the speaker <b>122</b> in the form of a beep or some like audio sounding mechanism. The audible and/or visual notification may also be sent via the network to the hospital system <b>140</b> (or any other remote station) and displayed on the display <b>146</b> of the hospital system <b>140</b> or played through speakers <b>152</b> of the hospital system <b>140</b>, or routed to the cell phone or pager of the user. In some examples, the audible alarm using the speakers <b>122</b> is turned off by a user selection <b>434</b> on the display <b>116</b> or it is silenced for a preconfigured time. The display <b>116</b>, <b>146</b> may show information <b>230</b> that includes the patient's intravenous treatment information <b>230</b><i>a </i>or to the patient's subcutaneous treatment information <b>230</b><i>b</i>. In some examples, the user <b>40</b> selects the countdown timer <b>430</b> when the timer <b>430</b> indicates that the patient <b>10</b> is due for his or her blood glucose measurement. When the user <b>40</b> selects the timer <b>430</b>, the display <b>116</b>, <b>146</b> allows the user <b>40</b> to enter the current blood glucose value BG as shown in <figref idref="DRAWINGS">FIG. 4D</figref>. For intravenous patients <b>10</b>, the process <b>200</b> may ask the user <b>40</b> (via the display <b>116</b>, <b>146</b>) if the blood glucose is pre-meal blood glucose measurement (as shown in <figref idref="DRAWINGS">FIG. 4D</figref>). When the user <b>40</b> enters the information <b>230</b> (<figref idref="DRAWINGS">FIG. 4D</figref>), the user <b>40</b> selects a continue button to confirm the entered information <b>230</b>, which leads to the display <b>116</b>, <b>146</b> displaying blood glucose information <b>230</b><i>c </i>and a timer <b>430</b> showing when the next blood glucose measurement BG is due (<figref idref="DRAWINGS">FIG. 4E</figref>). In addition, the user <b>40</b> may enter the patient's blood glucose measurement BG at any time before the timer <b>430</b> expires, if the user <b>40</b> selects the ‘enter BG’ button <b>436</b>. Therefore, the user <b>40</b> may input blood glucose values BG at any time, or the user <b>40</b> may choose to start the Meal Bolus process <b>500</b> (see <figref idref="DRAWINGS">FIG. 5</figref>) by selecting the start meal button <b>438</b> (<figref idref="DRAWINGS">FIG. 4E</figref>), transition the patient to SubQ insulin therapy <b>600</b> (see <figref idref="DRAWINGS">FIG. 6</figref>), or discontinue treatment <b>220</b>.
0122Referring to <figref idref="DRAWINGS">FIGS. 5A-5D</figref>, in some implementations, the process <b>200</b> includes a process where the patient's blood glucose level BG is measured prior to the consumption of caloric intake and calculates the recommended intravenous mealtime insulin requirement necessary to control the patient's expected rise in blood glucose levels during the prandial period. When a user <b>40</b> chooses to start the Meal Bolus process <b>500</b> (e.g., when the user <b>40</b> positively answers that this is a pre-meal blood glucose measurement in <figref idref="DRAWINGS">FIG. 4D</figref>, or when the user <b>40</b> selects the start meal button <b>438</b> in <figref idref="DRAWINGS">FIG. 4E</figref>), the Meal Bolus process <b>500</b>, at decision block <b>504</b>, requests the blood glucose BG of the patient <b>10</b>. The user <b>40</b> enters the blood glucose value BG at <b>501</b> or the system <b>100</b> receives the blood glucose BG from a glucometer <b>124</b>. This blood glucose measurement is referred to herein as the Pre-Meal BG or BG1. In some examples, where the user <b>40</b> enters the information, the user <b>40</b> selects a continue button to confirm the entered information <b>230</b><i>c</i>. In some examples, the meal bolus process <b>500</b> is administered to a patient <b>10</b> over a total period of time T<sub>MealBolus</sub>. The total period of time T<sub>MealBolus </sub>is divided into multiple time intervals T<sub>MealBolus1 </sub>to T<sub>MealBolusN</sub>, where N is any integer greater than zero. In some examples, a first time interval T<sub>MealBolus1 </sub>runs from a Pre-Meal blood glucose value BG1 at measured at time T<sub>1</sub>, to a second blood glucose value BG2 at measured at time T<sub>2</sub>. A second time interval T<sub>MealBolus2 </sub>runs from the second blood glucose value BG2 measured at time T<sub>2 </sub>to the third blood glucose value BG3 measured at time T<sub>3</sub>. A third time interval T<sub>MealBolus3 </sub>runs from the third blood glucose value BG3 measured at time T<sub>3 </sub>to a fourth blood glucose value BG4 measured at time T<sub>4</sub>. In some implementations where the time intervals T<sub>MealBolusN </sub>are smaller than T<sub>Default</sub>, the user <b>40</b> should closely monitor and control over changes in the blood glucose of the patient <b>10</b>. For example, a total period of time T<sub>MealBolus </sub>equals 2 hours, and may be comprised of: T<sub>MealBolus1</sub>=30 minutes, T<sub>MealBolus2</sub>=30 minutes, and T<sub>MealBolus3</sub>=1 hour. This example ends on the fourth blood glucose measurement. When the Meal Bolus process <b>500</b> has been activated, an indication is displayed on the display <b>116</b>, <b>146</b> informing the user <b>40</b> that the process <b>500</b> is in progress. The Meal Bolus process <b>500</b> prompts the user <b>40</b> if the entered blood glucose value BG is the first blood glucose value prior to the meal by displaying a question on the patient display <b>116</b>. If the Meal Bolus process <b>500</b> determines that the entered blood glucose value BG is the first blood glucose value (BG1) prior to the meal, then the Meal Bolus process <b>500</b> freezes the current multiplier M from being adjusted and calculates a regular intravenous insulin rate IRR at block <b>512</b>. The regular intravenous insulin rate IRR may be determined using EQ. 3A. Meanwhile, at block <b>502</b>, the Meal Bolus process <b>500</b> loads preconfigured meal parameters, such as meal times, insulin type, default number of carbohydrates per meal, the total period of time of the meal bolus process T<sub>MealBolus</sub>, interval lengths (e.g., T<sub>MealBolus1</sub>, T<sub>MealBolus1 </sub>. . . T<sub>MealBolusN</sub>), and the percent, “C”, of the estimated meal bolus to be delivered in the first interval T<sub>MealBolus1</sub>. In some examples, when the system <b>100</b> includes a hospital electronic medical record system <b>140</b>, nutritional information and number of grams of carbohydrates are retrieved from the hospital electronic medical record systems <b>140</b> automatically. The Meal Bolus process <b>500</b> allows the user <b>40</b> to select whether to input a number of carbohydrates from a selection of standard meals (AcutalCarbs) or to use a custom input to input an estimated number of carbohydrates (EstimatedCarbs) that the patient <b>10</b> is likely to consume. The Meal Bolus process <b>500</b> then flows to block <b>506</b>, where the estimated meal bolus rate for the meal is calculated. The calculation process in block <b>506</b> is explained in two steps. The first step is calculation of a meal bolus (in units of insulin) in accordance with the following equation: <br />Estimated Meal Bolus=EstimatedCarbs/CIR (11A)<br /> where CIR is the Carbohydrate-to-Insulin Ratio, previously discussed.
0123The Meal Bolus process <b>500</b> then determines the Estimated Meal Bolus Rate based on the following equation: <br />Estimated Meal Bolus Rate=Estimated Meal Bolus*<i>C/T</i><sub>MealBolus1</sub> (11B)<br /> Where, T<sub>MealBolus1 </sub>is the time duration of the first time interval of the Meal Bolus total period of time T<sub>MealBolus</sub>. C is a constant adjusted to infuse the optimum portion of the Estimated Meal Bolus during first time interval T<sub>MealBolus1</sub>. For instance: if Estimated Meal Bolus=6 units, T<sub>MealBolus1</sub>=0.5 hours, and C=25%, then applying Eq. 11A as an example: <br />Estimated Meal Bolus Rate=(6 units)*25%/(0.5 hours)=3 units/hour (11C)<br /> The Meal Bolus process <b>500</b> calculates the Total Insulin Rate at block <b>508</b> as follows: <br />Total Insulin Infusion Rate=Estimated Meal Bolus Rate+Regular Intravenous Rate (12)
0124The Meal Bolus process <b>500</b> flows to block <b>510</b> where it sets the time interval for the first interval T<sub>MealBolus1 </sub>to its configured value, (e.g., usually 30 minutes), which will end at the second meal bolus blood glucose (BG2).
0125After the first time interval T<sub>MealBolus1 </sub>expires (e.g., after 30 minutes elapse), the Meal Bolus process <b>500</b> prompts the user <b>40</b> to enter the blood glucose value BG once again at block <b>501</b>. When the Meal Bolus process <b>500</b> determines that the entered blood glucose value BG is not the first blood glucose value BG1 entered at block <b>504</b> (i.e., the pre-meal BG, BG1, as previously discussed), the process <b>500</b> flows to block <b>514</b>. At block <b>514</b>, the Meal Bolus process <b>500</b> determines if the blood glucose value BG is the second value BG2 entered by the user <b>40</b>. If the user <b>40</b> confirms that the entered blood glucose value BG is the second blood glucose value BG2 entered, the Meal Bolus process <b>500</b> uses the just-entered blood glucose BG2 to calculate the intravenous insulin rate IRR at block <b>516</b> and flows to block <b>524</b>. Simultaneously, if the blood glucose is the second blood glucose BG2, the Meal Bolus process <b>500</b> prompts the user <b>40</b> to enter the actual amount of carbohydrates that the patient <b>10</b> received at block <b>518</b>. The Meal Bolus process <b>500</b> then determines at decision block <b>520</b> and based on the inputted amount of actual carbohydrates, if the patient did not eat, i.e., if the amount of carbohydrates is zero. If the Meal Bolus process <b>500</b> determines that the patient did not eat, the Meal Bolus process <b>500</b> then flows to block <b>540</b>, where the meal bolus process <b>500</b> is discontinued, the multiplier is no longer frozen, and the time interval T<sub>Next </sub>is restored to the appropriate time interval T<sub>Next</sub>, as determined by process <b>400</b>. If however, the Meal Bolus process <b>500</b> determines that the patient <b>10</b> ate, i.e., the actual carbohydrates is not zero, then The Meal Bolus process <b>500</b> flows to block <b>522</b>, where it calculates a Revised meal bolus rate according to the following equations, where the Revised Meal Bolus and then an amount of insulin (in units of insulin) are calculated: <br />Revised Meal Bolus=ActualCarbs/CIR (13A)
0126The process at block <b>522</b> then determines the amount (in units of insulin) of estimated meal bolus that has been delivered to the patient <b>10</b> so far: <br />Estimated Meal Bolus Delivered=Estimated Meal Bolus Rate*(<i>T</i><sub>2</sub><i>−T</i><sub>1</sub>) (13B)<br /> where time T<b>1</b> is the time of when the first blood glucose value BG1 is measured and time T<b>2</b> is the time when the second blood glucose value BG2 is measured.
0127The process at block <b>522</b> then calculates the portion of the Revised Meal Bolus remaining to be delivered (i.e., the Meal Bolus that has not yet been delivered to the patient <b>10</b>) as follows: <br />Revised Meal Bolus Remaining=Revised Meal Bolus−Estimated Meal Bolus Delivered (13C)
0128The process at block <b>522</b> then calculates the Revised Meal Bolus Rate as follows: <br />Revised Meal Bolus Rate=Revised Meal Bolus Remaining/Time Remaining (14A)<br /> where Time Remaining=T<sub>MealBolus</sub>−T<sub>MealBolus1</sub>. Since the total time interval T<sub>MealBolus </sub>and the first time interval T<sub>MealBolus1 </sub>are preconfigured values, the Time Remaining may be determined.
0129The Meal Bolus process <b>500</b> calculates the total insulin rate at block <b>524</b> by adding the Revised Meal Bolus Rate to the regular Intravenous Rate (IIR), based on the blood glucose value BG: <br />Total Insulin Rate=Revised Meal Bolus Rate+IIR (14B)
0130The Meal Bolus process <b>500</b> flows to block <b>526</b> where it sets the time interval T<sub>Next </sub>to the second interval T<sub>MealBolus2</sub>, which will end at the third meal bolus blood glucose BG3 e.g., usually 30 minutes.
0131After the second interval, T<sub>MealBolus2 </sub>expires (e.g., 30 minutes), the Meal Bolus process <b>500</b> prompts the user <b>40</b> to enter the blood glucose value BG once again at block <b>501</b>. The Meal Bolus process <b>500</b> determines that the entered blood glucose value BG is not the first blood glucose value entered at block <b>504</b> (previously discussed) and flows to block <b>514</b>. The Meal Bolus process <b>500</b> determines that the entered blood glucose value BG is not the second blood glucose value entered at block <b>514</b> (previously discussed) and flows to block <b>528</b>. At block <b>528</b>, the Meal Bolus process <b>500</b> determines if the blood glucose value BG is the third value entered. If the entered blood glucose value BG is the third blood glucose value BG entered, the Meal Bolus process <b>500</b> calculates the intravenous insulin rate IRR at block <b>530</b> and flows to block <b>532</b>.
0132At block <b>532</b> the process determines the Total Insulin Rate by adding the newly-determined Regular Intravenous Insulin Rate (IIR) to the Revised Meal Bolus Rate, which was determined at BG2 and remains effective throughout the whole meal bolus time, T<sub>mealbolus</sub>.
0133The Meal Bolus process <b>500</b> flows to block <b>534</b> where it sets the time interval T<sub>Next </sub>to the third interval T<sub>MealBolus3 </sub>for the fourth meal bolus blood glucose, e.g., usually 60 minutes. In some implementations, more than 3 intervals (T<sub>MealBolus1</sub>, T<sub>MealBolus2 </sub>T<sub>MealBolus3</sub>) may be used. Additional intervals T<sub>MealBolusN </sub>may also be used and the process handles the additional intervals T<sub>MealBolusN </sub>similarly to how it handles the third time interval T<sub>MealBolus3</sub>. As discussed in the current example, the third interval T<sub>MealBolus3 </sub>is the last time interval, which ends with the measurement of the fourth blood glucose measurement BG4.
0134After the third time interval, T<sub>MealBolus3</sub>, expires (e.g., 60 minutes), the Meal Bolus process <b>500</b> prompts the user <b>40</b> to enter the blood glucose value BG once again at block <b>501</b>. The Meal Bolus process <b>500</b> determines that the entered blood glucose value BG is not the first blood glucose value entered at block <b>504</b> (previously discussed) and flows to block <b>514</b>. The Meal Bolus process <b>500</b> determines that the entered blood glucose value BG is not the second blood glucose value entered at block <b>514</b> (previously discussed), nor the third blood glucose level entered at block <b>528</b> and flows to block <b>536</b>.
0135At block <b>536</b>, the Meal Bolus process <b>500</b> determines that the inputted blood glucose is the fourth blood glucose value BG4. In this example, the fourth blood glucose value BG4 is the last one. The process <b>500</b> then flows to block <b>538</b> where the multiplier is no longer frozen, and the time interval T<sub>Next </sub>is restored to the appropriate time interval T<sub>Next</sub>, as determined by the process <b>400</b> (<figref idref="DRAWINGS">FIG. 4A</figref>). At this time, the Meal Bolus process <b>500</b> ends and the user <b>40</b> is prompted with a message indicating that the Meal Bolus process <b>500</b> is no longer active.
0136As shown in <figref idref="DRAWINGS">FIG. 4E</figref>, the process <b>200</b> provides a countdown timer <b>430</b> that alerts the user <b>40</b> when the next blood glucose measurement is due. The countdown timer <b>430</b> may be on the display <b>116</b> of the patient device <b>110</b> or displayed on the display <b>146</b> of the hospital system <b>140</b>. When the timer <b>430</b> is complete, a “BG Due!” message might be displayed as shown in <figref idref="DRAWINGS">FIG. 4B</figref>. Moreover, the timer <b>430</b> may be a countdown timer or a meal timer indicating a sequence of mealtime intervals (e.g., breakfast, lunch, dinner, bedtime, mid-sleep).
0137In some implementations, a Meal Bolus process <b>500</b> may be implemented by the following process on a processor <b>112</b>, <b>132</b>, <b>142</b>. Other processes may also be used.
0138<tables id="TABLE-US-00002" num="00002"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><thead><row><entry /><entry namest="offset" nameend="1" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /><entry>function PreMealIIR($PatientID, $CurrentBG, $Multiplier,</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>$InsulinConcentration,</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>$EstCarbs, $ActualCarbs, $TimeInterval,</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>$InsulinUnitsOfMeasure, $MealBolusCount) {</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>$iir = array( );</entry></row><row><entry /><entry>$CarbInsulinRatio = CIR($PatientID);</entry></row><row><entry /><entry>$NormalInsulin = ($CurrentBG − 60) * $Multiplier;</entry></row><row><entry /><entry>if($MealBolusCount == 0)</entry></row><row><entry /><entry>{</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>//first run − Premeal Bolus</entry></row><row><entry /><entry>$MealBolus = ($EstCarbs /$CarbInsulinRatio);</entry></row><row><entry /><entry>if($MealBolus <0)</entry></row><row><entry /><entry>{$MealBolus = 0;}</entry></row><row><entry /><entry>$iir[0] = $NormalInsulin + ( $MealBolus *.5 );</entry></row><row><entry /><entry>$iir[2] = ( $MealBolus *.5 );</entry></row><row><entry /><entry>/*</entry></row><row><entry /><entry>print “Premeal: MX: ” . $Multiplier . “<BR>”;</entry></row><row><entry /><entry>print ($CurrentBG − 60) * $Multiplier;</entry></row><row><entry /><entry>print “ + ” ;</entry></row><row><entry /><entry>print ( $MealBolus *.5 );</entry></row><row><entry /><entry>*/</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>} else if($MealBolusCount == 1){</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>//second run Post Meal Bolus</entry></row><row><entry /><entry>//third run time interval coming in is actually the</entry></row><row><entry /><entry>//difference between the premeal BG and the first Post Meal</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>BG (second run)</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>$MealBolus = ($ActualCarbs / $CarbInsulinRatio);</entry></row><row><entry /><entry>$OldMealBolus = ($EstCarbs / $CarbInsulinRatio);</entry></row><row><entry /><entry>$CurrentMealBolus = ($MealBolus − ($OldMealBolus</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>*.5 * $TimeInterval))/1.5;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>if($CurrentMealBolus <0)</entry></row><row><entry /><entry>{$CurrentMealBolus =0;}</entry></row><row><entry /><entry>$iir[0] = $NormalInsulin + $CurrentMealBolus ;</entry></row><row><entry /><entry>$iir[2] = $CurrentMealBolus ;</entry></row><row><entry /><entry>/*</entry></row><row><entry /><entry>print “PlateCheck: <BR>MX: ” . $Multiplier . “<BR>”;</entry></row><row><entry /><entry>print “Est Carbs: ” . $EstCarbs . “<BR>”;</entry></row><row><entry /><entry>print “ActualCarbs: ” . $ActualCarbs . “<BR>”;;</entry></row><row><entry /><entry>print “CarbInsulinRatio: ” . $CarbInsulinRatio . “<BR>”;</entry></row><row><entry /><entry>print “TimeInterval: ” . $TimeInterval . “<BR>”;</entry></row><row><entry /><entry>print “Multiplier: ” . $Multiplier;</entry></row><row><entry /><entry>*/</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row><row><entry /><entry>else</entry></row><row><entry /><entry>{</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>$MealBolus = ($ActualCarbs / $CarbInsulinRatio);</entry></row><row><entry /><entry>$OldMealBolus = ($EstCarbs / $CarbInsulinRatio);</entry></row><row><entry /><entry>/*</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="56pt" align="left" /><colspec colname="1" colwidth="161pt" align="left" /><tbody valign="top"><row><entry /><entry>print “Actual Carbs: ” . $ActualCarbs . “<BR>”;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>print “Est Carbs: ” . $EstCarbs . “<BR>”;</entry></row><row><entry /><entry>print “CIR: ” . $CarbInsulinRatio . “<BR>”;</entry></row><row><entry /><entry>print “Multiplier: ” . $Multiplier . “<BR>”;</entry></row><row><entry /><entry>print “CurrentBG: ” . $CurrentBG . “<BR>”;</entry></row><row><entry /><entry>print “IIR: ” . (($CurrentBG − 60) * $Multiplier) . “<BR>”;</entry></row><row><entry /><entry>print “MealBolus: ” . $MealBolus . “<BR>”;</entry></row><row><entry /><entry>print “OldMealBolus: ” . $OldMealBolus . “<BR>”;</entry></row><row><entry /><entry>print “TimeInterval: ” . $TimeInterval . “<BR>”;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><tbody valign="top"><row><entry /><entry>*/</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>$CurrentMealBolus = ($MealBolus − ($OldMealBolus</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry>*.5 * $TimeInterval))/1.5;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>if($CurrentMealBolus <0)</entry></row><row><entry /><entry>{$CurrentMealBolus =0;}</entry></row><row><entry /><entry>$iir[0] = $NormalInsulin + $CurrentMealBolus;</entry></row><row><entry /><entry>$iir[2] = $CurrentMealBolus;</entry></row><row><entry /><entry>/*</entry></row><row><entry /><entry>print “Post PlateCheck: <BR>MX: ” . $Multiplier .</entry></row><row><entry /><entry>“<BR>”;</entry></row><row><entry /><entry>print “IIR: ”;</entry></row><row><entry /><entry>print ($CurrentBG − 60) * $Multiplier . “<BR>”;</entry></row><row><entry /><entry>print “Est Carbs: ” . $EstCarbs . “<BR>”;</entry></row><row><entry /><entry>print “Acutal Carbs: ” . $ActualCarbs . “<BR>”;</entry></row><row><entry /><entry>print “Old Meal bolus: ” . $OldMealBolus . “<BR>”;</entry></row><row><entry /><entry>print “TimeInterval: ” . $TimeInterval . “<BR>”;</entry></row><row><entry /><entry>print “Meal bolus: ” . $MealBolus . “<BR>”;</entry></row><row><entry /><entry>print “Final Calc: ” . $iir[0];</entry></row><row><entry /><entry>*/</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row><row><entry /><entry>if ($InsulinUnitsOfMeasure != “units/hr”)</entry></row><row><entry /><entry>{</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="175pt" align="left" /><tbody valign="top"><row><entry /><entry>$iir[0] = $iir[0]/$InsulinConcentration;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row><row><entry /><entry>return $iir;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row><row><entry /><entry namest="offset" nameend="1" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0139Referring to <figref idref="DRAWINGS">FIGS. 2A and 6A-6B</figref>, if the user elects to initiate the SubQ Transition process <b>600</b>, the SubQ Transition process <b>600</b> determines at decision block <b>604</b> if the current blood glucose BG is within a preconfigured stability target range BG<sub>STR</sub>, e.g., 70-180 mg/dl, which is usually wider than the prescribed Target Range, BG<sub>TR</sub>. If the blood glucose BG is not within the preconfigured stability target range BG<sub>STR </sub>(e.g., BG<sub>Low</sub><BG<BG<sub>High</sub>), the SubQ Transition process <b>600</b> at block <b>606</b> displays a warning notification on the patient display <b>116</b>. Then, at lock <b>610</b>, the SubQ Transition process <b>600</b> is automatically discontinued.
0140Referring back to block <b>604</b>, if the blood glucose BG is within the preconfigured stability target range BG<sub>STR </sub>(e.g. 70-180 mg/dl), the SubQ Transition process <b>600</b> at decision block <b>608</b> determines if the patient's blood glucose measurement BG has been in the patient's personalized prescribed target range BG<sub>TR </sub>for the recommended stability period T<sub>Stable</sub>, e.g., 4 hours. If the SubQ Transition process <b>600</b> determines that the blood glucose value BG has not been in the prescribed target range BG<sub>STR </sub>for the recommended stability period T<sub>Stable</sub>, the SubQ Transition process <b>600</b> moves to block <b>614</b> where the system <b>100</b> presents the user <b>40</b> with a warning notification on the patient display <b>116</b>, explaining that the patient <b>10</b> has not been in the prescribed target range for the recommended stability period (see <figref idref="DRAWINGS">FIG. 6C</figref>). The SubQ Transition process <b>600</b> continues to decision block <b>618</b> where it determines whether the user <b>40</b> wants the patient <b>10</b> to continue the SubQ Transition process or to discontinue the SubQ Transition process. The SubQ Transition process <b>600</b> displays on the display <b>116</b> of the patient device <b>110</b> the question to the user <b>40</b> as shown in <figref idref="DRAWINGS">FIG. 6C</figref>. If the user <b>40</b> chooses to discontinue the SubQ Transition process, the SubQ Transition process <b>600</b> flows to block <b>624</b>, where the SubQ Transition process is discontinued.
0141Referring back to block <b>618</b>, if the user <b>40</b> chooses to override the warning and continue the SubQ Transition process, the process <b>600</b> prompts the user <b>40</b> to enter SubQ information <b>617</b> as shown in <figref idref="DRAWINGS">FIG. 6E</figref>. The SubQ Transition process <b>600</b> flows to block <b>616</b>, where the patient's SubQ Transition dose is calculated as a patient's total daily dose TDD. In some implementations, TDD is calculated in accordance with equation: <br />TDD=QuickTransitionConstant*<i>M</i><sub>Trans</sub> (15A)<br /> where QuickTransitionConstant is usually 1000, and M<sub>Trans </sub>is the patient's multiplier at the time of initiation of the SubQ transition process.
0142Referring again to block <b>616</b>, in some implementations TDD is calculated by a statistical correlation of TDD as a function of body weight. The following equation is the correlation used: <br />TDD=0.5*Weight (kg) (15B)
0143The SubQ Transition process <b>600</b> continues to block <b>620</b>, where the recommended SubQ dose is presented to the user <b>40</b> (on the display <b>116</b>) in the form of a Basal recommendation and a Meal Bolus recommendation (see <figref idref="DRAWINGS">FIG. 6F</figref>).
0144Referring again to decision block <b>608</b>, if the SubQ Transition process <b>600</b> determines that the patient <b>10</b> has been in the prescribed target range BG<sub>TR </sub>for the recommended stability period, T<sub>Stable</sub>, SubQ Transition process <b>600</b> continues to block <b>612</b>, where the patient's total daily dose TDD is calculated in accordance with the following equation: <br />TDD=(BG<sub>Target</sub><i>−K</i>)*(<i>M</i><sub>Trans</sub>)*24 (16)<br /> where M<sub>Trans </sub>is the patient's multiplier at the time of initiation of the SubQ transition process.
0145In some implementations, the patient's total daily dose TDD may be determined by the following process on a processor <b>112</b>, <b>132</b>, <b>142</b>. Other processes may also be used.
0146<tables id="TABLE-US-00003" num="00003"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><thead><row><entry /><entry namest="offset" nameend="1" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /><entry>function getIV_TDD($PatientID)</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><tbody valign="top"><row><entry /><entry>{</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="28pt" align="left" /><colspec colname="1" colwidth="189pt" align="left" /><tbody valign="top"><row><entry /><entry>//$weight = getOneField(“weight”, “patients”, “patientID”,</entry></row><row><entry /><entry>$PatientID);</entry></row><row><entry /><entry>//return $weight/2;</entry></row><row><entry /><entry>$CI = get_instance( );</entry></row><row><entry /><entry>$CI−>load−>model(‘options’);</entry></row><row><entry /><entry>$d = $CI−>options−>GetIVTDDData($PatientID);</entry></row><row><entry /><entry>$TargetHigh = $d[“TargetHigh”];</entry></row><row><entry /><entry>$TargetLow = $d[“TargetLow”];</entry></row><row><entry /><entry>$Multiplier = $d[“Multiplier”];</entry></row><row><entry /><entry>$MidPoint = ($TargetHigh + $TargetLow) / 2;</entry></row><row><entry /><entry>$Formula = ($MidPoint − 60) * $Multiplier * 24;</entry></row><row><entry /><entry>return $Formula;</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><tbody valign="top"><row><entry /><entry>}</entry></row><row><entry /><entry namest="offset" nameend="1" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0147When the patient's total daily dose TDD is calculated, the SubQ Transition process <b>600</b> continues to block <b>620</b> where the recommended SubQ dose is presented to the user <b>40</b> as described above. The SubQ Transition process <b>600</b> continues to block <b>622</b>, where the SubQ Transition process <b>600</b> provides information to the user <b>40</b> including a recommended dose of Basal insulin. The user <b>40</b> confirms that the Basal insulin has been given to the patient <b>10</b>; this starts a transitions timer using the TransitionRunTime<sub>Next</sub>, usually 4 hours. At this point, normal calculation rules governing the IIR are still in effect, including the intravenous IIR timer (process <b>400</b>), which continues to prompt for blood glucose tests at time intervals T<sub>Next </sub>as described previously. The SubQ Transition process <b>600</b> passes to decision block <b>626</b>, which determines whether the recommended time interval TransitionRunTime has elapsed, e.g., 4 hours, after which time the SubQ Transition process <b>600</b> continues to block <b>630</b>, providing the user with subcutaneous insulin discharge orders and exiting the IV Insulin process in block <b>634</b>.
0148Referring back to <figref idref="DRAWINGS">FIG. 2A</figref>, in some implementations, the subcutaneous program (at block <b>226</b>) includes six sub programs: a subcutaneous standard program (<figref idref="DRAWINGS">FIGS. 9A-9B</figref>); a subcutaneous for tube-fed patients Program (<figref idref="DRAWINGS">FIG. 10</figref>); a subcutaneous program with no meal boluses (<figref idref="DRAWINGS">FIG. 11</figref>); a meal-by-meal subcutaneous program without carbohydrate counting (<figref idref="DRAWINGS">FIG. 12</figref>); a meal-by-meal subcutaneous program with carbohydrate counting (<figref idref="DRAWINGS">FIGS. 13A-13B</figref>); and a subcutaneous program for non-diabetic patients (<figref idref="DRAWINGS">FIG. 14</figref>). Some functions or processes are used within the six subcutaneous programs such as determining the general and pre-meal correction (<figref idref="DRAWINGS">FIG. 7</figref>), determining the adjustment factor AF (<figref idref="DRAWINGS">FIG. 8</figref>), and hypoglycemia treatment.
0149Referring to <figref idref="DRAWINGS">FIG. 7</figref>, correction boluses CB are used in the six subprograms of SubQ program (block <b>226</b>, <figref idref="DRAWINGS">FIG. 2</figref>); because of this, correction boluses CB may be incorporated into a function having variables such as the blood glucose measurement BG of a patient <b>10</b>, a patient's personalized target blood glucose BG<sub>Target</sub>, and a correction factor CF. Thus, correction boluses CB are described as a function of the blood glucose measurement BG, the target blood glucose BG<sub>Target</sub>, and the correction factor CF (see EQ. 19 below). The process <b>700</b> calculates the correction bolus CB immediately after a blood glucose value BG of a patient <b>10</b> is measured. Once a calculation of the correction bolus CB is completed, a nurse <b>40</b> administers the correction bolus CB to the patient <b>10</b>, right after the blood glucose value BG is measured and used to calculate the correction bolus CB.
0150In some examples, the process <b>700</b> may determine the total daily dose TDD of insulin once per day, for example, every night at midnight. Other times may also be available. In addition, the total daily dose TDD may be calculated more frequently during the day, in some examples, the total daily dose TDD is calculated more frequently and considers the total daily dose TDD within the past 24 hours. The process <b>700</b> provides a timer <b>702</b>, such as a countdown timer <b>702</b>, where the timer <b>702</b> determines the time the process <b>700</b> executes. The timer <b>702</b> may be a count up timer or any other kind of timer. When the timer <b>702</b> reaches its expiration or reaches a certain time (e.g., zero for a countdown timer <b>702</b>), the timer <b>702</b> executes the process <b>700</b>. The counter <b>702</b> is used to determine at what time the process <b>704</b> calculates the total daily dose TDD. If the counter is set to 24 hours for example, then decision block <b>704</b> checks if the time has reached 24 hours, and when it does, then the process <b>700</b> calculates the total daily dose TDD of insulin. The correction bolus process <b>700</b> determines a total daily dose of insulin TDD, based on the following equation: <br />TDD=Sum over previous day (all basal+all meal boluses+all correction boluses) (17)
0151After the process <b>700</b> determines the total daily dose TDD of insulin at block <b>706</b>, the process <b>700</b> determines a Correction Factor CF immediately thereafter at block <b>710</b>, using the calculated total daily dose TDD from block <b>706</b> and Eq. 17. The correction factor CF is determined using the following equation: <br />CF=CFR/TDD (18)<br /> where CFR is a configurable constant stored in the non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> of the system. At block <b>708</b>, the process <b>700</b> retrieves the configurable constant CFR value from the non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> to calculate the correction factor CF at block <b>710</b>. The configurable constant CFR is determined from a published statistical correlation and is configurable by the hospital, nurses and doctors. The flexibility of modifying the correction constant CF, gives the system <b>100</b> flexibility when a new published configurable constant CFR is more accurate than the one being used. In some examples, the configurable constant CFR is a configurable constant set to <b>1700</b>, other values may also be available. In some examples, the total daily dose TDD and CF are determined once per day (e.g., at or soon after midnight).
0152Once the correction factor CF is determined in EQ. 18, the process <b>700</b> determines the correction bolus insulin dose at block <b>714</b> using the following equation: <br />CB=(BG−BG<sub>Target</sub>)/CF (19)<br /> where BG is the blood glucose measurement of a patient <b>10</b> retrieved at block <b>712</b>, BG<sub>Target </sub>is the patient's personalized Target blood glucose, and CF is the correction factor. The process <b>700</b> returns the correction bolus CB at block <b>716</b>. Rapid-acting analog insulin is currently used for Correction Boluses because it responds quickly to a high blood glucose BG. Also rapid acting analog insulin is currently used for meal boluses; it is usually taken just before or with a meal (injected or delivered via a pump). Rapid-acting analog insulin acts very quickly to minimize the rise of patient's blood sugar which follows eating.
0153A Correction Bolus CB is calculated for a blood glucose value BG at any time during the process <b>200</b>. Pre-meal Correction Boluses CB, are calculated using EQ. 19. In the Pre-meal Correction Bolus equation (19) there is no need to account for Remaining Insulin I<sub>Rem </sub>because sufficient time has passed for almost all of the previous meal bolus to be depleted. However, post-prandial correction boluses (after-meal correction boluses) are employed much sooner after the recent meal bolus and use different calculations, that account for remaining insulin I<sub>Rem </sub>that remains in the patient's body after a recent meal bolus. Rapid-acting analog insulin is generally removed by a body's natural mechanisms at a rate proportional to the insulin remaining I<sub>Rem </sub>in the patient's body, causing the remaining insulin I<sub>Rem </sub>in the patient's body to exhibit a negative exponential time-curve. Manufacturers provide data as to the lifetime of their insulin formulations. The data usually includes a half-life or mean lifetime of the rapid-acting analog insulin. The half-life of the rapid-acting analog insulin may be converted to mean lifetime iLifeRapid for rapid-acting insulin by the conversion formula: <br />iLifeRapid=Half-life*ln(2) (20)<br /> where ln(2) is the natural logarithm {base e} of two.
0154The present invention uses the mean lifetime iLifeRapid in its formulas (EQ. 20). Since the manufacturers and brands of insulin are few, the system <b>100</b> maintains the Half-life or iLifeRapid value of each insulin manufacturer up-to-date.
0155The insulin remaining in the patient's body Remaining Insulin I<sub>Rem </sub>is determined by multiplying the most recent insulin bolus {Meal Bolus, Correction Bolus, or combined bolus} times a time-dependent exponentially-declining factor as follows:
0156<maths id="MATH-US-00003" num="00003"><math overflow="scroll"><mtable><mtr><mtd><mrow><msub><mi>I</mi><mi>Rem</mi></msub><mo>=</mo><mrow><mrow><mrow><mo>(</mo><mrow><mi>Previous</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><mi>Bolus</mi></mrow><mo>)</mo></mrow><mo>*</mo><msup><mi>e</mi><mrow><mo>-</mo><mrow><mo>(</mo><mfrac><mrow><msub><mi>T</mi><mi>Current</mi></msub><mo>-</mo><msub><mi>T</mi><mi>Previous</mi></msub></mrow><mi>iLifeRapid</mi></mfrac><mo>)</mo></mrow></mrow></msup></mrow><mo>=</mo><mrow><mrow><mo>(</mo><mrow><mi>Previous</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><mi>Bolus</mi></mrow><mo>)</mo></mrow><mo>*</mo><mrow><mi>EXP</mi><mo></mo><mrow><mo>(</mo><mrow><mo>-</mo><mrow><mo>(</mo><mfrac><mrow><msub><mi>T</mi><mi>Current</mi></msub><mo>-</mo><msub><mi>T</mi><mi>Previous</mi></msub></mrow><mi>iLifeRapid</mi></mfrac><mo>)</mo></mrow></mrow><mo>)</mo></mrow></mrow></mrow></mrow></mrow></mtd><mtd><mrow><mo>(</mo><mn>21</mn><mo>)</mo></mrow></mtd></mtr></mtable></math></maths><img file="US10255992B2_D0003.tif" />
0157where T<sub>Current </sub>is the current time, and T<sub>PrevBolus </sub>is the time at which the last bolus was given to the patient <b>10</b>. The Post Meal Correction bolus CB<sub>post </sub>is calculated similar to an ordinary correction bolus CB (EQ. 19) with a deduction of the remaining insulin I<sub>Rem </sub>in the patient's body:
0158<maths id="MATH-US-00004" num="00004"><math overflow="scroll"><mtable><mtr><mtd><mrow><msub><mi>CB</mi><mi>post</mi></msub><mo>=</mo><mrow><mfrac><mrow><mo>(</mo><mrow><mi>BG</mi><mo>-</mo><msub><mi>BG</mi><mi>Target</mi></msub></mrow><mo>)</mo></mrow><mi>CF</mi></mfrac><mo>-</mo><mrow><mrow><mo>(</mo><mrow><mi>Previous</mi><mo></mo><mstyle><mspace width="0.8em" height="0.8ex" /></mstyle><mo></mo><mi>Bolus</mi></mrow><mo>)</mo></mrow><mo></mo><msup><mi>e</mi><mrow><mo>-</mo><mrow><mo>(</mo><mfrac><mrow><msub><mi>T</mi><mi>Current</mi></msub><mo>-</mo><msub><mi>T</mi><mi>Previous</mi></msub></mrow><mi>iLifeRapid</mi></mfrac><mo>)</mo></mrow></mrow></msup></mrow></mrow></mrow></mtd><mtd><mrow><mo>(</mo><mn>22</mn><mo>)</mo></mrow></mtd></mtr></mtable></math></maths><img file="US10255992B2_D0004.tif" />
0159In some examples, Post Meal Correction doses CB<sub>Post </sub>(EQ. 22) are taken into consideration only if they are positive (units of insulin), which means a negative value post meal correction bolus CB<sub>Post </sub>cannot be used to reduce the meal bolus portion of a new combined bolus.
0160Referring to <figref idref="DRAWINGS">FIG. 8</figref>, the process <b>800</b> describes a function that determines an Adjustment Factor AF based on an input of a Governing Blood GlucoseBGgov. The Adjustment Factor AF is used by the six subcutaneous subprograms: a subcutaneous standard program (<figref idref="DRAWINGS">FIGS. 9A-9B</figref>); a subcutaneous for tube-fed patients Program (<figref idref="DRAWINGS">FIG. 10</figref>); a subcutaneous program without meal boluses (<figref idref="DRAWINGS">FIG. 11</figref>); a meal-by-meal subcutaneous program without carbohydrate counting (<figref idref="DRAWINGS">FIG. 12</figref>); a meal-by-meal subcutaneous program with carbohydrate counting (<figref idref="DRAWINGS">FIGS. 13A-13B</figref>); and a subcutaneous program for non-diabetic patients (<figref idref="DRAWINGS">FIG. 14</figref>). These six subprograms adjust the insulin dose administered to a patient <b>10</b>. An adjustment factor process <b>800</b>, applied to Basal doses and Meal Boluses, determines an adjusted Recommended Basal dose RecBasal, or a Recommended Meal Bolus RecMealBol, by applying a unit-less Adjustment Factor AF to the preceding recommendation of the same dose, RecBasal<sub>prev</sub>, or RecMealBol<sub>prev</sub>. All dose adjustments are governed by a Governing Blood Glucose value BG<sub>gov</sub>. The Governing Blood Glucose values BG<sub>gov </sub>in the process are selected based on the criteria of preceding the previous occurrence of the dose to be adjusted by a sufficient amount of time for the effect (or lack of effect) of the insulin to be observable and measurable in the value of the BG<sub>gov</sub>.
0161At block <b>802</b>, the adjustment factor process <b>800</b> receives the Governing Glucose value BG<sub>gov </sub>from non-transitory memory <b>24</b>, <b>114</b>, <b>144</b>, since the adjustment factor AF is determined using the Governing Glucose value BG<sub>gov</sub>. To determine the adjustment factor AF, the adjustment factor process <b>800</b> considers the blood glucose target range BG<sub>TR </sub>(within which Basal doses and Meal Boluses, are not changed), which is defined by a lower limit, i.e., a low target BG<sub>TRL </sub>and an upper limit, i.e., a high target BG<sub>TRH</sub>. As previously discussed, the target range BG<sub>TR </sub>is determined by a doctor <b>40</b> and entered manually (e.g., using the patient device <b>110</b> or the medical record system <b>140</b>, via, for example, a drop down menu list displayed on the display <b>116</b>, <b>146</b>). Each target range BG<sub>TR </sub>is associated with a set of configurable constants including a first constant BG<sub>AFL</sub>, a second constant BG<sub>AFH1</sub>, and a third constant BG<sub>AFH2 </sub>shown in the below table.
0162<tables id="TABLE-US-00004" num="00004"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="center" /><thead><row><entry namest="1" nameend="1" rowsep="1">TABLE 1</entry></row></thead><tbody valign="top"><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row><row><entry>Target Range Settings</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="6"><colspec colname="1" colwidth="49pt" align="center" /><colspec colname="2" colwidth="35pt" align="center" /><colspec colname="3" colwidth="35pt" align="center" /><colspec colname="4" colwidth="35pt" align="center" /><colspec colname="5" colwidth="35pt" align="center" /><colspec colname="6" colwidth="28pt" align="center" /><tbody valign="top"><row><entry>Input Ranges</entry><entry>BG<sub>AFL</sub></entry><entry>BG<sub>TRL</sub></entry><entry>BG<sub>TRH</sub></entry><entry>BG<sub>AFH1</sub></entry><entry>BG<sub>AFH2</sub></entry></row><row><entry namest="1" nameend="6" align="center" rowsep="1" /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="6"><colspec colname="1" colwidth="49pt" align="center" /><colspec colname="2" colwidth="35pt" align="char" char="." /><colspec colname="3" colwidth="35pt" align="char" char="." /><colspec colname="4" colwidth="35pt" align="char" char="." /><colspec colname="5" colwidth="35pt" align="char" char="." /><colspec colname="6" colwidth="28pt" align="char" char="." /><tbody valign="top"><row><entry> 70-100</entry><entry>70</entry><entry>70</entry><entry>100</entry><entry>140</entry><entry>180</entry></row><row><entry> 80-120</entry><entry>80</entry><entry>80</entry><entry>120</entry><entry>160</entry><entry>200</entry></row><row><entry>100-140</entry><entry>70</entry><entry>100</entry><entry>140</entry><entry>180</entry><entry>220</entry></row><row><entry>120-160</entry><entry>90</entry><entry>120</entry><entry>160</entry><entry>200</entry><entry>240</entry></row><row><entry>140-180</entry><entry>110</entry><entry>140</entry><entry>180</entry><entry>220</entry><entry>260</entry></row><row><entry namest="1" nameend="6" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0163The adjustment factor process <b>800</b> determines, at block <b>804</b>, if the Governing Glucose value BG<sub>gov </sub>is less than or equal to the first constant BG<sub>AFL </sub>(BG<sub>gov</sub><=BG<sub>AFL</sub>), if so then at block <b>806</b>, the adjustment factor process <b>800</b> assigns the adjustment factor AF to a first pre-configured adjustment factor AF1 shown in Table 2.
0164If, at block <b>804</b>, the Governing Glucose value BG<sub>gov </sub>is not less than the first constant BG<sub>AFL</sub>, (i.e., BG<sub>gov</sub>≥BG<sub>AFL</sub>), then at block <b>808</b>, the adjustment factor process <b>800</b> determines if the Governing Glucose value BG<sub>gov </sub>is greater than or equal to the first constant BG<sub>AFL </sub>and less than the low target BG<sub>TRL </sub>of the target range BG<sub>TR </sub>(BG<sub>AFL</sub>≤BG<sub>gov</sub><BG<sub>TRL</sub>). If so, then the adjustment factor process <b>800</b> assigns the adjustment factor AF to a second pre-configured adjustment factor AF2, at block <b>810</b>. If not, then at block <b>812</b>, the adjustment factor process <b>800</b> determines if the Governing Glucose value BG<sub>gov </sub>is greater than or equal to the low target BG<sub>TRL </sub>of the target range BG<sub>TR </sub>and less than the high target level BG<sub>TRH </sub>of the target range BG<sub>TR </sub>(BG<sub>TRL</sub>≤BG<sub>gov</sub><BG<sub>TRH</sub>). If so, then the adjustment factor process <b>800</b> assigns the adjustment factor AF to a third pre-configured adjustment factor AF3, at block <b>814</b>. If not, then at block <b>816</b>, the adjustment factor process <b>800</b> determines if the Governing Glucose value BG<sub>gov </sub>is greater than or equal to the high target level BG<sub>TRH </sub>of the target range BG<sub>TR </sub>and less than the second constant BG<sub>AFH1 </sub>(BG<sub>TRH</sub>≤BG<sub>gov</sub><BG<sub>AFH1</sub>). If so, then the adjustment factor process <b>800</b> assigns the adjustment factor AF to a fourth pre-configured adjustment factor AF4, at block <b>818</b>. If not, then at block <b>820</b>, the adjustment factor process <b>800</b> determines if the Governing Glucose value BG<sub>gov </sub>is greater than or equal to the second constant BG<sub>AFH1 </sub>and less than the third constant BG<sub>AFH2 </sub>(BG<sub>AFH1</sub>≤BG<sub>gov</sub><BG<sub>AFH2</sub>). If so, then the adjustment factor process <b>800</b> assigns the adjustment factor AF to a fifth pre-configured adjustment factor AF5, at block <b>822</b>. If not, then at block <b>824</b>, the adjustment factor process <b>800</b> determines that the Governing Glucose value BG<sub>gov </sub>is greater than or equal to the third constant BG<sub>AFH2 </sub>(BG<sub>gov</sub>≥BG<sub>AFH2</sub>); and the adjustment factor process <b>800</b> assigns the adjustment factor AF to a sixth pre-configured adjustment factor AF6, at block <b>826</b>. After assigning a value to AF the adjustment factor process <b>800</b> returns the adjustment factor AF to the process requesting the adjustment factor AF at block <b>828</b> (e.g., the subcutaneous process (<figref idref="DRAWINGS">FIGS. 9A-9B</figref>)).
0165<tables id="TABLE-US-00005" num="00005"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="center" /><thead><row><entry namest="1" nameend="1" rowsep="1">TABLE 2</entry></row><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row><row><entry>Configurable values for Adjustment Factor AF</entry></row><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="offset" colwidth="56pt" align="left" /><colspec colname="1" colwidth="35pt" align="center" /><colspec colname="2" colwidth="126pt" align="char" char="." /><tbody valign="top"><row><entry /><entry>AF1 =</entry><entry>0.8</entry></row><row><entry /><entry>AF2 =</entry><entry>0.9</entry></row><row><entry /><entry>AF3 =</entry><entry>1</entry></row><row><entry /><entry>AF4 =</entry><entry>1.1</entry></row><row><entry /><entry>AF5 =</entry><entry>1.2</entry></row><row><entry /><entry>AF6 =</entry><entry>1.3</entry></row><row><entry /><entry namest="offset" nameend="2" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0166In some examples, a patient <b>10</b> may suffer from hypoglycemia during the execution of the process <b>200</b>. Hypoglycemia treatment may be needed in the Intravenous process <b>300</b> (<figref idref="DRAWINGS">FIGS. 3A and 3B</figref>) and <b>400</b> (<figref idref="DRAWINGS">FIG. 4A</figref>) or in the SubQ standard process <b>900</b> (<figref idref="DRAWINGS">FIGS. 9A and 9B</figref>). The process <b>200</b> includes a sub-process that monitors the current blood glucose value BG of a patient <b>10</b> and determines if it is less than a hypoglycemia threshold BG<sub>Hypo </sub>(configurable by the hospital or doctor). If the current blood glucose value BG is less than the hypoglycemia threshold BG<sub>Hypo</sub>, a warning message is displayed on the display <b>116</b>, <b>146</b> warning the patient <b>10</b>, the nurse and the doctor <b>40</b> of the patient's condition, the value of the low current blood glucose value BG, a reminder to turn off the insulin (if the hypoglycemia event occurs in the IV Process (<figref idref="DRAWINGS">FIG. 2</figref>)), and a selector that allows the nurse or doctor <b>40</b> to select the type of glucose administered to the patient <b>10</b>. Some of the selections include: Intravenous D50 (50% glucose by weight) if the patient <b>10</b> has an intravenous connection; and Oral glucose (tablets or gel). Once the nurse or doctor <b>40</b> enters, using the patient device <b>110</b> or the medical record system <b>140</b>, a type of glucose to be administered to the patient, the process <b>200</b> calculates a dose recommendation (or prescribed dose) and displays the calculated dose on the display <b>116</b>, <b>146</b>. Moreover, the process <b>200</b> prompts the nurse or doctor <b>40</b> to input via the patient device <b>110</b> or the hospital device <b>140</b>, the dose D<sub>hypo </sub>administered to the patient <b>10</b> to treat the hypoglycemia by grams of glucose may be determined based on the following equation: <br /><i>D</i><sub>hypo</sub>(in grams)=<i>F</i><sub>HypoTreatment</sub>*(BG<sub>Target</sub>−BG) (23)<br /> where BG<sub>TR </sub>is the blood glucose target range and F<sub>HypoTreatment </sub>is a hypoglycemia treatment factor that is a configurable constant. In some examples, the hypoglycemia treatment factor F<sub>HypoTreatment </sub>equals 0.2 (glucose gm/(mg/dl)).
0167If the nurse or doctor <b>40</b> selected a solution (e.g., D50 as opposed to oral glucose), the process <b>200</b> uses a different formula to calculate the recommended dose, where the calculated grams of glucose are divided by the concentration of glucose C<sub>HypoFluidConc </sub>in the fluid in (grams of glucose/ml) to obtain the recommended dose in units of solution volume (e.g., ml). The formula is: <br /><i>D</i><sub>hypo</sub>(in ml)=(BG<sub>TR</sub>−BG)*<i>F</i><sub>HypoTreatment</sub><i>/C</i><sub>HypoFluidConc</sub> (24)<br /> For D50, the hypoglycemic fluid concentration is 0.5 grams of glucose/ml.
0168Referring to <figref idref="DRAWINGS">FIGS. 2A and 9A-9B</figref>, if the user <b>40</b> initiates a subcutaneous insulin process <b>900</b> at block <b>210</b> or block <b>600</b>, also referred to as a Standard SubQ Program, the subcutaneous insulin process <b>900</b> requests the user <b>40</b> to enter SubQ information <b>617</b> for the patient <b>10</b>, such as patient diabetes status, subcutaneous type ordered for the patient <b>10</b> (e.g., Basal/bolus and correction that is intended for patients on a consistent carbohydrate diet, or Basal and correction that is intended for patients who are NPO or on continuous eternal feeds), total daily dosage (TDD) (e.g., calculated using any of EQs. 15A-15C), bolus insulin type (e.g., Novolog), basil insulin type (e.g., Lantus) and frequency of distribution (e.g., 1 dose per day, 2 doses per day, 3 doses per day, etc.), basil time, basal percentage of TDD, meal bolus percentage of TDD, daily meal bolus distribution (e.g., breakfast bolus, lunch bolus and dinner bolus), or any other relevant information. In some implementations, the patient SubQ information <b>617</b> is prepopulated with default parameters, which may be adjusted or modified. In some examples, portions of the patient SubQ information <b>617</b> is prepopulated with previously entered patient subcutaneous information <b>216</b><i>a</i>. The subcutaneous insulin process <b>900</b> may prompt the request to the user <b>40</b> to enter the SubQ information <b>617</b> on the display <b>116</b> of the patient device <b>110</b>. In some implementations, the subcutaneous insulin process <b>900</b> prompts the request to the user <b>40</b> to enter the SubQ information <b>617</b> on the display <b>116</b> of the patient device <b>110</b> for new SubQ patients after transitioning from being treated with an intravenous treatment as shown in <figref idref="DRAWINGS">FIG. 9C</figref>. For instance, the user <b>40</b> may select whether or not to continue treating the patient with the subcutaneous insulin process <b>900</b>. In other implementations, the subcutaneous insulin process <b>900</b> prompts the request on the display <b>116</b> for a custom start of new SubQ patients being treated with the subcutaneous insulin process <b>900</b> shown in <figref idref="DRAWINGS">FIG. 9D</figref>. In some examples, the subcutaneous insulin process <b>900</b> prompts the request on the display <b>116</b> for a weight-based start of SubQ patients being treated with the subcutaneous insulin process <b>900</b> as shown in <figref idref="DRAWINGS">FIG. 9E</figref>. For instance, the user <b>40</b> may input the weight (e.g., 108 kg) of the patient <b>10</b>, and in some examples, the TDD may be calculated using EQ. 15B based on the patient's weight.
0169Basal insulin is for the fasting insulin-needs of a patient's body. Therefore, the best indicator of the effectiveness of the basal dose is the value of the blood glucose BG after the patient <b>10</b> has fasted for a period of time. Meal Boluses are for the short-term needs of a patient's body following a carbohydrate-containing meal. Therefore, the best indicator of the effectiveness of the Meal Bolus is a blood glucose measurement BG tested about one mean insulin-lifetime iLifeRapid after the Meal Bolus, where the lifetime is for the currently-used insulin type. For rapid-acting analog insulin the lifetime is conveniently similar to the time between meals. The SubQ process <b>900</b> begins with the manual entry of a blood glucose value BG at block <b>902</b>. Then the SubQ process <b>900</b> determines the type of the blood glucose value BG, i.e., the time that the blood glucose BG is measured, e.g., midsleep, pre-breakfast, pre-lunch, pre-dinner, or bedtime. In some examples, the subcutaneous insulin process <b>900</b> includes a default setup of three meals per day, but a bedtime snack or other additional meals may be configurable.
0170At block <b>904</b>, the subcutaneous insulin process <b>900</b> determines if the blood glucose type BG<sub>type </sub>is Midsleep (measured during a patient's midsleep). If so, then the subcutaneous insulin process <b>900</b> calculates a midsleep correction dose CB<sub>Midsleep </sub>of insulin at block <b>914</b>, using the following equation (based on EQ. 2): <br />CB<sub>Midsleep</sub>=(BG<sub>Midsleep</sub>−BG<sub>Target</sub>)/CF; (25)<br /> or by the Correction Bolus Function, process <b>700</b>, (<figref idref="DRAWINGS">FIG. 7</figref>), and sends the blood glucose value BG at midsleep BG<sub>Midsleep </sub>(received at block <b>902</b>) to block <b>942</b>.
0171If the entered blood glucose BG is not measured during midsleep, i.e., BG<sub>type </sub>is not equal MidSleep, then the subcutaneous insulin process <b>900</b> determines if the blood glucose type BG<sub>type </sub>is measured before breakfast (BG<sub>type</sub>=pre-Breakfast) at block <b>906</b>. If so, then the subcutaneous insulin process <b>900</b> calculates a breakfast correction dose CB<sub>Breakfast </sub>of insulin at block <b>916</b>, using the following equation (based on EQ. 2): <br />CB<sub>Breakfast</sub>(BG<sub>Breakfast</sub>−BG<sub>Target</sub>)/CF; (26)<br /> and the patient <b>10</b> is administered the breakfast correction dose CB<sub>Breakfast </sub>as soon as possible. Block <b>906</b> sends the pre-breakfast blood glucose value to block <b>924</b> and block <b>950</b>. At block <b>924</b>, the nurse <b>40</b> administers the patient <b>10</b> with the breakfast bolus RecBreakBol<sub>(current)</sub>), and then passes the pre-breakfast blood glucose BG<sub>Breakfast </sub>to block <b>936</b> (where the next Recommendation for the Breakfast bolus is calculated after the pre-lunch BG<sub>type </sub>is entered). Once the pre-lunch blood glucose is entered at block <b>902</b>, and the adjustment factor parameter AF governed by the pre-lunch blood glucose is determined (<figref idref="DRAWINGS">FIG. 8</figref>), the adjustment factor AF is also sent to block <b>936</b>. At block <b>936</b>, the process <b>900</b> determines the next recommended Breakfast Bolus RecBreakBol<sub>(Next) </sub>based on the following equation: <br />RecBreakBol<sub>(Next)</sub>=(RecBreakBol<sub>(current)</sub>)*AF (27)<br /> At block <b>950</b>, the subcutaneous insulin process <b>900</b> determines if the pre-breakfast blood glucose BG<sub>Breakfast </sub>has been tested, if not then the subcutaneous insulin process <b>900</b> blocks basal recommendation, and blocks the Give Basal dose input sequence at button <b>960</b>, and posts a warning, displayed on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>954</b> and is stored in the non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>954</b>. However, if the pre-breakfast blood glucose BG<sub>Breakfast </sub>has been tested, then the subcutaneous insulin process <b>900</b> selects, at block <b>942</b>, the Governing blood glucose BG<sub>gov </sub>as the lesser of the two blood glucose values, i.e., the midsleep blood glucose BG<sub>Midsleep </sub>or the pre-breakfast blood glucose BG<sub>Breakfast</sub>, as shown in the following equation: <br />BG<sub>gov</sub>(for Basal adjustment)=MIN(BG<sub>Midsleep </sub>or BG<sub>Breakfast</sub>) (28)
0172In some implementations, the governing blood glucose BG<sub>gov </sub>for Basal is the lesser of the MidSleep blood glucose BG<sub>Midsleep </sub>or the pre-breakfast blood glucose BG<sub>Breakfast </sub>unless the system <b>100</b> determines that the MidSleep blood glucose BG<sub>Midsleep </sub>caused a Correction bolus dose CB greater than a maximum value (MSCorrMAX), and the following equation applies: <br />(Time of BG<sub>Breakfast</sub>−Time of BG<sub>Midsleep </sub>Correction dose)<DTmin (29)<br /> where DT<sub>min </sub>is a preset time window. In other words:
0173<tables id="TABLE-US-00006" num="00006"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><thead><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry> {</entry></row><row><entry>IF {(TbreakfastBG − TMSCorr) > DTmin} AND</entry></row><row><entry> {MidSleep Correction > MSCorrMAX} THEN</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="2"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="203pt" align="left" /><tbody valign="top"><row><entry /><entry>{BGgov for Basal} = MAX{ pre-breakfastBG, MidSleepBG}</entry></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="left" /><tbody valign="top"><row><entry> ELSE {BGgov for Basal} = MIN{pre-breakfastBG, MidSleepBG}</entry></row><row><entry>}</entry></row><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0174After determining the governing blood glucose BG<sub>gov</sub>, the subcutaneous insulin process <b>900</b> determines the adjustment factor AF at block <b>944</b> (see. <figref idref="DRAWINGS">FIG. 8</figref>). The adjustment factor process <b>800</b>, returns the adjustment factor AF as a function of the governing blood glucose BG<sub>gov</sub>. The subcutaneous insulin process <b>900</b> sends the adjustment factor AF to block <b>946</b>, where the subcutaneous insulin process <b>900</b> determines the adjustment to the patient's insulin dose by the following equation: <br />RecomBasal=(previous RecomBasal<sub>PM</sub>)*AF, (30)<br /> and the nurse <b>40</b> give the patient <b>10</b> the Recommended basal dose RecomsBasal at block <b>948</b>.
0175In some implementations, where the patient <b>10</b> receives multiple Basal doses per day, the subcutaneous insulin process <b>900</b> provides the patient <b>10</b> with equal doses each time. Therefore, the recommended basal doses RecomBasal for a full day are equal to the first recommended basal dose of Eq. 30. This makes it possible to administer the morning Basal dose RecomBasal immediately after the pre-Breakfast BG has been tested.
0176For meal Bolus adjustments, the adjustment is applied to the meal bolus of the same meal of the previous day (known as the Governing Meal Bolus MB<sub>gov</sub>). An equivalent statement is that the next day's meal bolus is the adjustment applied to the current meal bolus. The adjustment is based on the Governing Blood Glucose BG<sub>gov</sub>, which is the next scheduled blood glucose BG, following the Governing Meal Bolus MB<sub>gov</sub>. The adjustment value is determined by the Adjustment Factor process <b>800</b> (<figref idref="DRAWINGS">FIG. 8</figref>), whose input is the Governing Blood Glucose BG<sub>gov </sub>and whose output is the adjustment factor AF. The adjustment factor AF is multiplied by the Governing Meal Bolus MB<sub>gov </sub>to obtain the adjusted Recommended Meal Bolus RecMealBol.
0177If either the governing blood glucose BG<sub>gov </sub>or the governing meal bolus MB<sub>gov </sub>is missing, then the previous day's Recommended Meal Bolus RecMealBol<sub>prev </sub>is kept in place.
0178The SubQ process <b>900</b> is designed with three meals during the day, Breakfast, Lunch, Dinner. Considering the lunch as the meal, after the blood glucose BG is manually entered at block <b>902</b>, the SubQ process <b>900</b>, at block <b>908</b>, determines that the blood glucose type, BG<sub>type </sub>is pre-lunch, i.e., BG<sub>Lunch</sub>. the SubQ process <b>900</b>, at block <b>918</b> determines the correction dose based on the following equation (based on EQ. 2): <br />CB<sub>Lunch</sub>=(BG<sub>Lunch</sub>−BG<sub>Target</sub>)/CF, (31)
0179Once the SubQ process <b>900</b> determines the correction dose, the dose is displayed on the display <b>114</b>, <b>146</b> so that the nurse <b>40</b> can administer the dose to the patient <b>10</b> as soon as possible.
0180The current Recommended Lunch Bolus is available at block <b>962</b>; it has been available since the previous day's pre-Dinner BG. This current Recommended Lunch Bolus is displayed on the display, and the nurse gives the Lunch Bolus RecLunchBol<sub>Current </sub>at block <b>926</b>. The SubQ process <b>900</b> does not determine a new recommended dose until the pre-Dinner blood glucose is tested at block <b>910</b>. Then the pre-dinner blood glucose BG serves as the BG<sub>gov </sub>for the Lunch Bolus and the SubQ process sends the BG<sub>gov </sub>to block <b>932</b>, which is the input/output box of the adjustment factor process <b>800</b>. The adjustment factor process <b>800</b> returns the adjustment factor parameter AF, which is in turn sent to block <b>938</b>. At block <b>938</b>, the process determines the Next Recommended Lunch Bolus, RecLunchBol<sub>Next </sub>based on the following equation: <br />RecLunchBol<sub>Next</sub>=RecLunchBol<sub>Current</sub>*AF (32)
0181The other meals, Breakfast and Dinner follow the same pattern as the example of Lunch set forth above.
0182Considering dinner as the meal, after the blood glucose BG is manually entered at block <b>902</b>, the SubQ process <b>900</b>, at block <b>910</b>, determines that the blood glucose type, BG<sub>type </sub>is pre-dinner. The SubQ process <b>900</b>, at block <b>920</b> determines the correction dose based on the following equation (based on EQ. 2): <br />CB<sub>Dinner</sub>=(BG<sub>Dinner</sub>−BG<sub>Target</sub>)/CF, (33)
0183Once the SubQ process <b>900</b> determines the correction dose, the dose is displayed on the display <b>116</b>, <b>146</b> so that the nurse <b>40</b> can administer the dose to the patient <b>10</b> as soon as possible.
0184The current Recommended Dinner Bolus RecDinnerBolus<sub>Current </sub>is available at block <b>962</b>; it has been available since the previous day's Bedtime blood glucose<sub>Bedtime</sub>. This current Recommended Dinner Bolus is displayed on the display, and the nurse gives the patient <b>10</b> the recommended Dinner Bolus RecDinnerBolus<sub>current </sub>at block <b>928</b>. The SubQ process <b>900</b> does not determine a new recommended dose RecomBolus until the bedtime blood glucose is tested at block <b>912</b>. Then the bedtime blood glucose BG serves as the BG<sub>gov </sub>for the dinner Bolus and the SubQ process sends the BG<sub>gov </sub>to block <b>934</b>, which is the input/output box of the adjustment factor process <b>800</b>. The adjustment factor process <b>800</b> returns the adjustment factor parameter AF, which is in turn sent to block <b>940</b>. At block <b>940</b>, the process <b>900</b> determines the Next recommended Dinner Bolus RecDinnerBolus<sub>Next </sub>based on the following equation: <br />RecDinnerBolus<sub>Next</sub>=RecDinnerBolus<sub>current</sub>*AF (34)
0185When the SubQ process <b>900</b> determines that the blood glucose BG type BG<sub>type </sub>is bedtime BG<sub>Bedtime </sub>(i.e., the blood glucose BG is taken at bedtime) at block <b>912</b>, the SubQ process <b>900</b> determines at block <b>922</b> the correction dose (based on EQ. 2): <br />CB<sub>Bedtime</sub>=(BG<sub>Bedtime</sub>−BG<sub>Target</sub>)/CF, (35)
0186As previously mentioned, the SubQ process <b>900</b> is configurable to add additional blood glucose BG measurements having blood glucose type BG<sub>type </sub>of miscellaneous, as shown in block <b>956</b>. The SubQ process <b>900</b> determines a correction dose at block <b>958</b>. <br />RecMiscBoluS<sub>Next</sub>=(RecMiscBolus<sub>Current</sub>)*AF (36)
0187<figref idref="DRAWINGS">FIG. 10</figref> shows the SubQ for Tube-Fed Patients process <b>1000</b> for critically ill patients who are ordered nil per os (NPO), which means that oral food and fluids are withheld from the patient <b>10</b>. This process <b>1000</b> is designed specifically for patients <b>10</b> who are receiving a nutrition formula via a tube to the stomach or intravenous TPN (total parenteral nutrition). TPN is when the patient <b>10</b> is only receiving nutritional benefits intravenously. Neither TPN nor Tube-Fed patients require meal boluses because they are not eating meals. Instead, they are given equal boluses of Rapid-Acting insulin at equally-spaced scheduled times around the clock to meet the continuous insulin needs of their continuous tube-feeding or TPN nutrition; these boluses are called Equal-Boluses (EqBolus).
0188SubQ for Tube-Fed Patients process <b>1000</b> allows the nurse or doctor <b>40</b> to divide the day into equal intervals, via the display <b>110</b>, <b>114</b>. In addition, the nurse or doctor <b>40</b> can choose the number of scheduled blood glucose measurements BG per day, which equals the number of intervals per day. Each interval includes a scheduled blood glucose measurement BG and an Equal-Bolus EqBolus. The scheduled blood glucose times are: Tsched1; Tsched2; Tsched3 . . . etc., with associated blood glucoses BG1; BG2; BG3 . . . etc. The SubQ for Tube-Fed Patients process <b>1000</b> displays the time and BG number of the next-scheduled blood glucose, via the display <b>110</b>, <b>114</b> at block <b>1040</b>. Optionally, the SubQ for Tube-Fed Patients process <b>1000</b> may employ a countdown timer <b>1050</b> to obtain the blood glucose measurements BG at the proper times.
0189To prevent the BG schedule from “migrating around the clock-face”, the following method is used: The SubQ for Tube-Fed Patients process <b>1000</b> determines if the time at which the blood glucose BG was measured BG<sub>Time </sub>falls within one of the intervals listed above. If so, then the countdown timer <b>1050</b> is set to time-out on the next scheduled blood glucose time Tsched1, Tsched2, Tsched3, . . . etc. Each interval is configured with a start time margin (M<sub>Start</sub>) and an end time margin (M<sub>End</sub>). The SubQ for Tube-Fed Patients process <b>1000</b> may be summarized as follows:
0000IF [(T<sub>sched1</sub>−M<sub>Start</sub>)<BG<sub>Time</sub><=(T<sub>sched1</sub>+M<sub>End</sub>)]; THEN Set countdown timer to time-out at T<sub>sched2</sub>;
0000IF [(T<sub>sched2</sub>−M<sub>Start</sub>)<BG<sub>Time</sub><=(T<sub>sched2</sub>+M<sub>End</sub>)]; THEN Set countdown timer to time-out at T<sub>sched3 </sub>. . . and so on.
0000In some examples, where there are four intervals configured, then the last interval's logic is as follows:
0000IF [(T<sub>sched4</sub>−M<sub>Start</sub>)<BG<sub>Time</sub><=(T<sub>sched4</sub>+M<sub>End</sub>)]; THEN Set countdown timer to time-out at T<sub>sched1</sub>.
0190In some implementations, the SubQ for Tube-Fed Patients process <b>1000</b> provides two blood glucose schedule plans: Six blood glucose BG tests per day; or four blood glucose BG tests per day. The nurse or doctor <b>40</b> can select which one to use for a specific patient <b>10</b>. The first blood glucose plan for six blood glucose measurements per day includes the following details: each scheduled blood glucose measurement is four hours apart from the next, e.g., 00:00, 04:00, 08:00, 12:00, 16:00, and 20:00, with a start margin M<sub>start </sub>of 2 hours and an end margin M<sub>end </sub>of 2 hours. If a blood glucose measurement BG falls within the interval(i) from {T<sub>sched</sub>(i)−2 hrs} to {T<sub>sched</sub>(i)+2 hrs} the Countdown Timer is set to expire on the next scheduled time, T<sub>sched </sub>(i+1).
0191The second blood glucose plan for four blood glucose measurements per day is shown in <figref idref="DRAWINGS">FIG. 10</figref>. <figref idref="DRAWINGS">FIG. 10</figref> further shows a miscellaneous blood glucose measurement that is not scheduled. The blood glucose measurements are each scheduled six hours apart from the next at 00:00, 06:00, 12:00, and 18:00, with a start margin M<sub>start </sub>of 4 hours and an end margin M<sub>end </sub>of 2 hours. If a the blood glucose measurement falls within the interval (i) from {T<sub>sched</sub>(i)−4 hrs} to {T<sub>shed</sub>(i)+2 hrs} the Countdown Timer is set to expire on the next scheduled BG T<sub>sched</sub>(i+1). All four of the blood glucose BG tests.
0192<tables id="TABLE-US-00007" num="00007"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="center" /><thead><row><entry namest="1" nameend="1" rowsep="1">TABLE 3</entry></row><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row><row><entry>Blood Glucose Measurement every 6 hours</entry></row><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="offset" colwidth="42pt" align="left" /><colspec colname="1" colwidth="63pt" align="left" /><colspec colname="2" colwidth="112pt" align="center" /><tbody valign="top"><row><entry /><entry>Start Margin (M<sub>Start</sub>)</entry><entry>4 hours</entry></row><row><entry /><entry>End Margin (M<sub>End</sub>)</entry><entry>2 hours</entry></row><row><entry /><entry>T<sub>sched</sub>1</entry><entry>00:00</entry></row><row><entry /><entry>T<sub>sched</sub>2</entry><entry>06:00</entry></row><row><entry /><entry>T<sub>sched</sub>3</entry><entry>12:00</entry></row><row><entry /><entry>T<sub>sched</sub>4</entry><entry>18:00</entry></row><row><entry /><entry namest="offset" nameend="2" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0193The SubQ for Tube-Fed Patients process <b>1000</b> starts with a manual blood glucose measurement BG entry accompanied by the blood glucose measurement time BG<sub>Time </sub>at block <b>1002</b>. At block <b>1080</b>, an interactive popup asks the user if the blood glucose is a “Scheduled BG” or a miscellaneous (‘Misc”) blood glucose test that is not scheduled. If the user chooses “Misc”, then the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1012</b>, assigns a value of “Misc” to the field BGype and records the date-time stamp (“Recorded time”). At block <b>1030</b>, the SubQ for Tube-Feeding process <b>1000</b> determines a correction dose CB for the manual blood glucose measurement, using EQ. 2. The SubQ for Tube-Fed patients process <b>1000</b> displays the correction dose CB on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>1040</b> and stores the value in non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1042</b>.
0194Returning to block <b>1080</b>, if the user chooses “Scheduled BG”, the SubQ for Tube-Fed Patients process <b>1000</b> determines, at block <b>1004</b>, if the blood glucose time BG<sub>Time </sub>is within the interval from (T<sub>sched</sub>1−M<sub>Start</sub>) to (T<sub>sched</sub>1+M<sub>End</sub>). If the blood glucose measurement time BG<sub>Time </sub>is within the interval, i.e., (T<sub>sched</sub>1−M<sub>Start</sub>)<BG<sub>Time </sub>(T<sub>sched</sub>1+M<sub>End</sub>), then the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1014</b>, assigns the value “BG1” to the field BG<sub>type</sub>, resets the countdown timer to T<sub>sched </sub>2 and displays a reminder of the next BG time on the display <b>116</b>, <b>146</b> at block <b>1040</b>. Then, the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1022</b>, determines the correction dose CB based on the blood glucose value BG1, using EQ. 2: <br />CB=(BG−BG<sub>Target</sub>)/CF (2)<br /> or using the Correction Dose Function, process <b>700</b>. The SubQ for Tube-Fed patients process <b>1000</b> displays the correction dose CB on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>1040</b> and stores the value in non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1042</b>. Additionally, the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1044</b>, uses the blood glucose value BG1 as the governing BG for adjusting the value of the four Equal-Boluses (EqBolus). Specifically, at block <b>1044</b>, the SubQ for Tube-Fed Patients process <b>1000</b> uses the blood glucose value BG1 as the input value BG<sub>gov </sub>for the Adjustment Factor (AF) function for determining a value for the AF. The SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1046</b>, retrieves the Previous Day's Recommended Equal-Bolus from memory <b>24</b>, <b>114</b>, <b>144</b>, and at block <b>1048</b>, determines a new value for the Recommended Equal-Bolus (e.g., all four EqBolus) by multiplying the AF value from block <b>1044</b> by the Previous Day's Recommended Equal-Bolus from block <b>1046</b>. The SubQ for Tube-Fed patients process <b>1000</b> displays the Recommended Equal-Bolus (EqBolus) on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>1040</b> and stores the value in non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1042</b>.
0195However, if at block <b>1004</b> the SubQ for Tube-Fed Patients process <b>1000</b> determines that the blood glucose measurement time BG<sub>Time </sub>is not within the interval from (T<sub>sched</sub>1−M<sub>Start</sub>) to (T<sub>sched</sub>1+M<sub>End</sub>), the SubQ for Tube-Fed Patients process <b>1000</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within a second interval (T<sub>sched</sub>2−M<sub>start</sub>) to (T<sub>sched</sub>2+M<sub>End</sub>) at block <b>1006</b>, and if so, then the SubQ for Tube-Fed Patients process <b>1000</b> at block <b>1016</b> assigns the value “BG2” to the field BGtype, resets the countdown timer to T<sub>sched</sub>3 and displays a reminder of the next BG time on the display <b>116</b>, <b>146</b> at block <b>1040</b>. Then, the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1024</b>, determines the correction dose CB based on the blood glucose value BG2, using EQ. 2 or using the Correction Dose Function, process <b>700</b>.
0196The SubQ for Tube-Fed patients process <b>1000</b> displays the correction dose CB on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>1040</b> and stores the value in non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1042</b>. Additionally, the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1036</b>, uses the blood glucose value BG2 as the governing BG for adjusting the Basal dose. Specifically, at block <b>1036</b>, the SubQ for Tube-Fed Patients process <b>1000</b> uses the blood glucose value BG2 as the input value BG<sub>gov </sub>for the Adjustment Factor (AF) function for determining a value for the AF.
0197The SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1056</b>, retrieves the last Basal dose of the previous day RecBasal<sub>Last </sub>from memory <b>24</b>, <b>114</b>, <b>144</b>, and at block <b>1058</b>, determines a current day's Recommended Basal Dose RecBasal by multiplying the AF value by the RecBasal<sub>Last</sub>, as follows: <br />RecBasal=(RecBasal<sub>Last</sub>)*AF (37)<br /> The SubQ for Tube-fed patients process <b>1000</b> displays the RecBasal on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>1040</b> and stores the value in non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1042</b>.
0198However, if at block <b>1006</b> the SubQ for Tube-Fed Patients process <b>1000</b> determines that the blood glucose measurement time BG<sub>Time </sub>is not within the interval from (T<sub>sched</sub>2−M<sub>Start</sub>) to (T<sub>sched</sub>2+M<sub>End</sub>), the SubQ for Tube-Fed Patients process <b>1000</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within a third interval (T<sub>sched</sub>3−M<sub>Start</sub>) to (T<sub>sched</sub>3+M<sub>End</sub>) at block <b>1008</b>, and if so, then the SubQ for Tube-Fed Patients process <b>1000</b> at block <b>1018</b> assigns the value “BG3” to the field BG<sub>type</sub>, resets the countdown timer to T<sub>sched</sub>4 and displays a reminder of the next BG time on the display <b>116</b>, <b>146</b> at block <b>1040</b>. Then, the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1026</b>, determines the correction dose CB based on the blood glucose value BG3, using EQ. 2 or using the Correction Dose Function, process <b>700</b>.
0199However, if at block <b>1008</b> the SubQ for Tube-Fed Patients process <b>1000</b> determines that the blood glucose measurement time BG<sub>Time </sub>is not within the interval from (T<sub>sched</sub>3−M<sub>Start</sub>) to (T<sub>sched</sub>3+M<sub>End</sub>), the SubQ for Tube-Fed Patients process <b>1000</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within a fourth interval (T<sub>sched</sub>4−M<sub>Start</sub>) to (T<sub>sched</sub>4+M<sub>End</sub>) at block <b>1010</b>, and if so, then the SubQ for Tube-Fed Patients process <b>1000</b> at block <b>1020</b> assigns the value “BG4” to the field BGtype, resets the countdown timer to T<sub>sched</sub>1 and displays a reminder of the next BG time on the display <b>116</b>, <b>146</b> at block <b>1040</b>. Then, the SubQ for Tube-Fed Patients process <b>1000</b>, at block <b>1028</b>, determines the correction dose CB based on the blood glucose value BG4, using EQ. 2 or using the Correction Dose Function, process <b>700</b>.
0200<figref idref="DRAWINGS">FIG. 11</figref> describes a SubQ Without Meal Boluses process <b>1100</b>, where the blood glucose measurements BG are deferred until after the meals, resulting in large after-meal correction boluses that incorporate insulin to cover the meals. The SubQ Without Meal Boluses process <b>1100</b> divides the day into intervals that may be of equal duration or unequal duration. Each interval includes a scheduled blood glucose measurement BG. In some examples, the SubQ Without Meal Boluses process <b>1100</b> includes five blood glucose measurements BG per day. The SubQ Without Meal Boluses process <b>1100</b> may be configured to include other numbers of time intervals. In addition, the SubQ Without Meal Boluses process <b>1100</b> includes configurable blood glucose BG measurement times. In some examples, the measurement schedule includes blood glucose measurements BG places about one to three hours after regular mealtimes, which is an appropriate timing for post-meal correction.
0201The scheduled Blood glucose measurement times BG times are named with a T<sub>sched</sub>0, T<sub>sched</sub>1, T<sub>sched</sub>2 etc. The Time-intervals are marked by Time Boundaries, named “T<sub>bound</sub>” with numbered subscripts. These time-values are configurable. An example of default times are shown in the following table:
0202<tables id="TABLE-US-00008" num="00008"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="1"><colspec colname="1" colwidth="217pt" align="center" /><thead><row><entry namest="1" nameend="1" rowsep="1">TABLE 4</entry></row><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row><row><entry>Default Times</entry></row><row><entry namest="1" nameend="1" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="offset" colwidth="21pt" align="left" /><colspec colname="1" colwidth="77pt" align="left" /><colspec colname="2" colwidth="119pt" align="left" /><tbody valign="top"><row><entry /><entry>T<sub>bound0 </sub>= 0:00</entry><entry>BG<sub>MidSleep</sub>: T<sub>sched1 </sub>= 03:00</entry></row><row><entry /><entry>T<sub>bound1 </sub>= 05:00</entry><entry>BG<sub>Before-Breakfast</sub>: T<sub>sched2 </sub>= 07:00</entry></row><row><entry /><entry>T<sub>bound2 </sub>= 08:00</entry><entry>BG<sub>After-Breakfast</sub>: T<sub>sched3 </sub>= 10:00</entry></row><row><entry /><entry>T<sub>bound3 </sub>= 11:00</entry><entry>BG<sub>After-Lunch</sub>: T<sub>sched4 </sub>= 15:00</entry></row><row><entry /><entry>T<sub>bound4 </sub>= 18:00</entry><entry>BG<sub>Bedtime</sub>: T<sub>sched5 </sub>= 22:00</entry></row><row><entry /><entry namest="offset" nameend="2" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
0203Similar to the SubQ for tube-fed patients process <b>1000</b> (<figref idref="DRAWINGS">FIG. 10</figref>), the SubQ Without Meal Boluses process <b>1100</b> (<figref idref="DRAWINGS">FIG. 11</figref>) includes a countdown timer <b>1101</b> used to obtain the blood glucose BG tests at the proper times.
0204To prevent the BG schedule from “migrating around the clock-face”, the following method is used:
0205The SubQ Without Meal Boluses process <b>1100</b> determines if the time at which the blood glucose BG was measured BG<sub>Time </sub>falls within one of the intervals. If so, then the countdown timer is set to time-out on the next interval's scheduled blood glucose measurement T<sub>sched1</sub>, T<sub>sched2</sub>, T<sub>sched3</sub>, . . . etc. This can be thought of as a “snap-to-the-schedule” feature. Each interval is configured with a start time margin (M<sub>Start</sub>) and an end time margin (M<sub>End</sub>). The SubQ Without Meal Boluses process <b>1100</b> may be summarized as follows:
0000IF [T<sub>bound0</sub><BG<sub>Time</sub>≤T<sub>bound1</sub>]; THEN Set countdown timer to time-out at T<sub>sched2 </sub>
0000IF [T<sub>bound1</sub><BG<sub>Time</sub>≤T<sub>bound2</sub>]; THEN Set countdown timer to time-out at T<sub>sched3 </sub>
0000IF [T<sub>bound2</sub><BG<sub>Time</sub>≤T<sub>bound3</sub>]; THEN Set countdown timer to time-out at T<sub>sched4 </sub>
0000IF [T<sub>bound3</sub><BG<sub>Time</sub>≤T<sub>bound4</sub>]; THEN Set countdown timer to time-out at T<sub>sched5 </sub>
0000IF [T<sub>bound4</sub><BG<sub>Time</sub>≤T<sub>bound0</sub>]; THEN Set countdown timer to time-out at T<sub>sched1 </sub>
0206The SubQ Without Meal Boluses process <b>1100</b> starts with a manual blood glucose measurement BG entry accompanied by the blood glucose measurement time BG<sub>Time </sub>at block <b>1102</b>. Then at block <b>1104</b>, the SubQ Without Meal Boluses process <b>1100</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within the interval from T<sub>bound0 </sub>to T<sub>bound1</sub>. If the blood glucose measurement time BG<sub>Time </sub>is within the interval, i.e., T<sub>bound0</sub><BG<sub>Time</sub>≤T<sub>bound1</sub>, then the SubQ Without Meal Boluses process <b>1100</b>, at block <b>1114</b>, resets the countdown timer to T<sub>sched</sub>2. Then the SubQ Without Meal Boluses process <b>1100</b>, determines a correction dose CB at block <b>1122</b>, using EQ. 2.
0207However, if at block <b>1104</b> the SubQ Without Meal Boluses process <b>1100</b> determines that the blood glucose measurement time BG<sub>Time </sub>is not within the interval from T<sub>bound0 </sub>to T<sub>bound1</sub>, the SubQ Without Meal Boluses process <b>1100</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within a second interval T<sub>bound1 </sub>to T<sub>bound2</sub>, and if so then the SubQ Without Meal Boluses process <b>1100</b> at block <b>1116</b>, resets the countdown timer to T<sub>sched</sub>3 and at block <b>1124</b>, determines a correction dose CB, using EQ. 2.
0208However, if at block <b>1106</b> the SubQ Without Meal Boluses process <b>1100</b> determines that the blood glucose measurement time BG<sub>Time </sub>is not within the interval from T<sub>bound1 </sub>to T<sub>bound2</sub>, the SubQ Without Meal Boluses process <b>1100</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within a third interval T<sub>bound2 </sub>to T<sub>bound3 </sub>at block <b>1108</b>, and if so then the SubQ Without Meal Boluses process <b>1100</b> at block <b>1118</b>, resets the countdown timer to T<sub>sched</sub>4 and at block <b>1126</b>, determines a correction dose CB, using EQ. 2.
0209However, if at block <b>1108</b> the SubQ Without Meal Boluses process <b>1100</b> determines that the blood glucose measurement time BG<sub>Time </sub>is not within the third time interval from T<sub>bound2 </sub>to T<sub>bound3</sub>, the SubQ Without Meal Boluses process <b>1100</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within a fourth interval T<sub>bound3 </sub>to T<sub>bound4</sub>, and if so then the SubQ Without Meal Boluses process <b>1100</b> at block <b>1120</b>, resets the countdown timer to T<sub>sched5 </sub>and at block <b>1128</b>, determines a correction dose CB, using EQ. 2.
0210However, if at block <b>1110</b> the SubQ Without Meal Boluses process <b>1100</b> determines that the blood glucose measurement time BG<sub>Time </sub>is not within the fourth time interval from T<sub>bound3 </sub>to T<sub>bound4</sub>, the SubQ Without Meal Boluses process <b>1100</b> determines if the blood glucose measurement time BG<sub>Time </sub>is within a fifth interval T<sub>bound4 </sub>to T<sub>bound5</sub>, and if so then the SubQ Without Meal Boluses process <b>1100</b> at block <b>1130</b>, resets the countdown timer to T<sub>sched1 </sub>and at block <b>1131</b>, determines a correction Dose CB, using EQ. 2.
0211As shown, the SubQ Without Meal Boluses process <b>1100</b> repeats itself five times since there are five scheduled blood glucose measurement BG; however, the SubQ Without Meal Boluses process <b>1100</b> may include more or less time intervals.
0212The SubQ Without Meal Boluses process <b>1100</b> adjusts the basal insulin dosage by first determining the Governing blood glucose BG<sub>gov </sub>at block <b>1134</b>. The SubQ Without Meal Boluses process <b>1100</b> determines the Governing blood glucose BG<sub>gov </sub>as the blood glucose BG closest to 06:00 earlier on the same day as the basal dose whose recommendation is being calculated. To insure that the closest blood glucose BG is obtained, the basal dose is not allowed until an elapsed time after 06:00 equal to the elapsed time from the preceding BG until 0600. This is to insure that all opportunity for “another BG closer to 0600” has passed.
0213The SubQ Without Meal Boluses process <b>1100</b> passes the Governing blood glucose BG<sub>gov </sub>from block <b>1134</b> to block <b>1136</b>, which determines the adjustment factor AF (see <figref idref="DRAWINGS">FIG. 8</figref>) and passes it to block <b>1138</b>. At block <b>1138</b>, the SubQ Without Meal Boluses process <b>1100</b> determines the current day's recommended first basal dose using the following equation: <br />RecBasal<sub>First</sub>=(RecBasal<sub>Last(prev)</sub>)*AF, (38)
0214The basal dose may be one of several administered to the patient <b>10</b> during the day, but all the doses are kept at the same value.
0215The process <b>1000</b> displays the correction dose CB and the recommended basal dose on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>1140</b> and stores the values in non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1142</b>.
0216Referring to <figref idref="DRAWINGS">FIG. 12</figref>, the Meal-by-Meal SubQ Without Carbohydrate-counting process <b>1200</b> calculates the Recommended Meal Bolus by employing the preceding Meal Bolus (of any type or time-of-day) as the Governing Meal Bolus MB<sub>gov </sub>and employing the next blood glucose following the Governing Meal Bolus as the Governing Blood Glucose BG<sub>gov</sub>. This means BG<sub>gov </sub>is often the current BG in real-time.
0217The Correction Boluses and Basal Dose adjustment are conducted similar to the Standard SubQ process <b>900</b> (<figref idref="DRAWINGS">FIGS. 9A and 9B</figref>). Therefore, a correction dose is determined at blocks <b>1214</b>, <b>1216</b>, <b>1218</b>, <b>1220</b>, <b>1222</b>, <b>1258</b> based on the blood glucose type.
0218The Meal Bolus Adjustment portion of the Meal-by-Meal without Carbohydrate-counting SubQ process <b>1200</b> begins with a manual blood glucose measurement BG entry at block <b>1202</b>. If the blood glucose measurement BG is determined by block <b>1204</b> to be a blood glucose type BG<sub>type </sub>of a Midsleep BG, then the process <b>900</b> sends the blood glucose measurement to block <b>1242</b>. If the blood glucose measurement BG is not a blood glucose type BG<sub>type </sub>of a Midsleep BG, then Meal-by-Meal Without carbohydrate counting SubQ process <b>1200</b> determines at block <b>1206</b> whether the BG is a pre-Breakfast blood glucose BG<sub>Breakfast</sub>. If the BG is determined at block <b>1206</b> to be a pre-Breakfast blood glucose BG<sub>Breakfast</sub>, then at block <b>1250</b>, the process <b>1200</b> determines if the pre-breakfast blood glucose BG<sub>Breakfast </sub>has been tested, if not then the process <b>1200</b> blocks basal recommendation, and blocks the initiation of the Give Basal popup at button <b>1260</b>, and posts a warning, displayed on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse and doctor <b>40</b> at block <b>1254</b> and is stored in the non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1251</b>. However, if the pre-breakfast blood glucose BG<sub>Breakfast </sub>has been tested, then the process <b>1200</b> selects, at block <b>1242</b>, the Governing blood glucose BG<sub>gov </sub>as the lesser of the two blood glucose values, i.e., the midsleep blood glucose BG<sub>Midsleep </sub>or the pre-breakfast blood glucose BG<sub>Breakfast</sub>, as shown in EQ. 28 (above).
0219After determining the governing blood glucose BG<sub>gov</sub>, the process <b>1200</b> determines the adjustment factor AF at block <b>1244</b> (see. <figref idref="DRAWINGS">FIG. 8</figref>). The adjustment factor process <b>800</b>, returns the adjustment factor AF as a function of the governing blood glucose BG<sub>gov</sub>. The process <b>1200</b> sends the adjustment factor AF to block <b>1246</b>, where the process <b>1200</b> determines the adjustment to the patient's insulin dose by the following EQ. 30, then the nurse <b>40</b> give the patient <b>10</b> the Recommended basal dose RecomsBasal at block <b>1248</b>.
0220If the Meal-by-Meal without carbohydrate counting SubQ process <b>1200</b>, at block <b>1206</b>, determines that the blood glucose measurement BG is not a pre-breakfast blood glucose measurement BG<sub>Breakfast</sub>, then it is passed to block <b>1208</b> where a determination is made whether the blood glucose measurement BG is a pre-Lunch blood glucose BG<sub>Lunch</sub>. If it is a pre-Lunch blood glucose BG<sub>Lunch</sub>, then block <b>1208</b> routes the pre-Lunch BG to block <b>1230</b> where it is used as the input (BG<sub>gov</sub>) for the AF Function. The AF Function returns a value of the Adjustment Factor (AF), which is routed to block <b>1238</b> where the Recommended Lunch Bolus is calculated by the following equation: <br />RecLunchBol=AF*RecBreakfastBol<sub>Prev</sub> (39)
0221The process <b>1200</b> sends the Recommended Lunch Bolus RecLunchBolus to the remote processor at block <b>1254</b>, to the display <b>114</b>, <b>146</b>, at block <b>1252</b>, and to block <b>1240</b> for Dinner bolus calculation.
0222If the blood glucose BG is determined at block <b>1208</b> to not be a pre-Lunch blood glucose BG<sub>Lunch</sub>, then it is routed to block <b>1210</b>. If the BG is determined by block <b>1210</b> to be a pre-Dinner blood glucose BG<sub>Dinner</sub>, then the blood glucose BG is routed to block <b>1232</b> where it is used as the input (BG<sub>gov</sub>) for the adjustment factor process <b>00</b>. The AF Function returns a value of the Adjustment Factor AF, which is routed to block <b>1240</b>. The preceding Recommended Lunch Bolus is available at block <b>1240</b>, which has all the necessary data to calculate the Recommended Dinner Bolus by the following equation: <br />RecDinnerBol=AF*(RecLunchBol<sub>Prev</sub>) (40)
0223The process <b>1200</b> sends the Recommended Dinner Bolus, RecDinnerBol to the remote processor at block <b>1254</b>, to the display <b>114</b>, <b>146</b>, block <b>1252</b>, and to block <b>1236</b> for the next day's Breakfast bolus calculation.
0224If the process <b>1200</b> determines the blood glucose BG at block <b>1210</b> to not be a pre-Dinner BG, then the process <b>1200</b> routes the blood glucose BG to block <b>1212</b>. If the process <b>1200</b> determines the blood glucose BG at block <b>1212</b> to be a Bedtime BG, then the process <b>1200</b> routes the BG to block <b>1234</b> where it is used as the input (BG<sub>gov</sub>) for the AF Function. The AF Function returns a value of the Adjustment Factor (AF), which is routed to block <b>1236</b>. The preceding Recommended Dinner Bolus (from the previous day) is available at block <b>1236</b>, which has all the necessary data to calculate the Recommended Breakfast Bolus by the following equation: <br />RecBreakfastBol=AF*(RecDinnerBol<sub>Prev</sub>) (41)
0225The process <b>1200</b> sends the Recommended Breakfast Bolus to the remote processor at block <b>1254</b>, to the Subject Data Display, block <b>1252</b>, and to block <b>1238</b> for Lunch bolus calculation.
0226The Meal-by-Meal SubQ With Carbohydrate-counting program calculates the Recommended Meal Bolus by dividing the carbohydrates in the upcoming meal by CIR (Carbohydrate-to-Insulin Ratio). The Carbohydrate-to-Insulin Ratio CIR is in the form of a single parameter that is re-calculated at each meal and passed to the next meal. The Governing CIR is defined as the CIR passed to the current meal from the preceding meal. The process employs the next blood glucose BG following the Governing CIR as the Governing BG (BG<sub>gov</sub>). This means BG<sub>gov </sub>is often the current BG in real-time.
0227The Correction Boluses and Basal Dose adjustment are conducted similar to the Standard SubQ process <b>900</b> (<figref idref="DRAWINGS">FIGS. 9A and 9B</figref>). Therefore, a correction dose CB is determined at blocks <b>1314</b>, <b>1316</b>, <b>1318</b>, <b>1320</b>, <b>1322</b>, <b>1258</b> based on the blood glucose type.
0228Referring to <figref idref="DRAWINGS">FIGS. 13A and 13B</figref>, the Meal Bolus Adjustment portion of the Meal-by-Meal Process <b>1300</b> begins with a manual BG entry at block <b>1302</b>. If the process <b>1300</b> determines the blood glucose value BG at block <b>1304</b> to not be a Midsleep BG, then the process <b>1300</b> makes a determination at block <b>1306</b> whether the BG is a pre-Breakfast BG. If the process <b>1300</b> determines the blood glucose BG at block <b>1308</b> to be a pre-Breakfast blood glucose BG<sub>breakfast</sub>, then at block <b>1350</b>, the process <b>1300</b> determines if the pre-breakfast blood glucose BG<sub>Breakfast </sub>has been tested. If not, then the process <b>1300</b> blocks basal recommendation, and blocks the initiation of the Give Basal dialog at button <b>1360</b>, and posts a warning, displayed on the display <b>116</b>, <b>146</b>, to the patient <b>10</b>, nurse, and doctor <b>40</b> at block <b>1354</b>. The process <b>1300</b> stores the warning in the non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> at block <b>1351</b>. If, however, the pre-breakfast blood glucose BG<sub>Breakfast </sub>has been tested, then the process <b>1300</b> selects, at block <b>1342</b>, the Governing blood glucose BG<sub>gov </sub>as the lesser of the two blood glucose values, i.e., the midsleep blood glucose BG<sub>Midsleep </sub>or the pre-breakfast blood glucose BG<sub>Breakfast</sub>, as shown in EQ. 28 (above).
0229After determining the governing blood glucose BG<sub>gov</sub>, the process <b>1300</b> determines the adjustment factor AF at block <b>1344</b> (see. <figref idref="DRAWINGS">FIG. 8</figref>). The adjustment factor process <b>800</b> returns the adjustment factor AF as a function of the governing blood glucose BG<sub>gov</sub>. The process <b>1300</b> sends the adjustment factor AF to block <b>1246</b>, where the process <b>1300</b> determines the adjustment to the patient's insulin dose by the following EQ. 30, then the nurse <b>40</b> gives the patient <b>10</b> the Recommended basal dose RecomsBasal at block <b>1348</b>.
0230If the process <b>1300</b> determines the blood glucose BG at block <b>1306</b> to not be a pre-Breakfast BG, then the process <b>1300</b> passes the blood glucose BG to block <b>1308</b>, where the process <b>1300</b> determines whether the blood glucose BG is a pre-lunch blood glucose BG<sub>lunch</sub>. If the blood glucose BG is a pre-Lunch blood glucose BG<sub>lunch</sub>, then the process <b>1300</b>, at block <b>1308</b>, routes the pre-lunch blood glucose BG<sub>lunch </sub>to block <b>1330</b>, where it is used as the input (BG<sub>gov</sub>) for the adjustment factor AF Function. The adjustment factor AF Function (<figref idref="DRAWINGS">FIG. 8</figref>) returns a value of the Adjustment Factor AF, which is routed to block <b>1334</b> where the Carbohydrate-to-Insulin Ratio (CIR) is calculated by the following formula: <br />CIR=(CIR from Breakfast)/AF (42)
0231The Meal-by-Meal with Carb-Counting process <b>1300</b> routes the Carbohydrate-to-Insulin Ratio CIR to block <b>1338</b> where the Recommended Lunch Bolus is calculated as follows: <br />RecLunchBolus=(Carbohydrate gms in Lunch)/CIR (43)
0232The Carbohydrate-to-Insulin Ratio CIR is also sent from block <b>1334</b> to block <b>1336</b> for use in the upcoming Dinner calculations.
0233If the process <b>1300</b> determines the blood glucose BG at block <b>1308</b> to not be a pre-lunch blood glucose BG<sub>lunch</sub>, then the process <b>1300</b> routes the blood glucose BG to block <b>1310</b>. If the process <b>1300</b> determines the blood glucose BG at block <b>1310</b> to be pre-dinner blood glucose BG<sub>dinner</sub>, then the process <b>1300</b> routes the blood glucose BG to block <b>1332</b>, where it is used as the input (BG<sub>gov</sub>) for the adjustment factor AF Function. The adjustment factor AF Function returns a value of the Adjustment Factor (AF), which the process <b>1300</b> routes to block <b>1336</b>, where the Carbohydrate-to-Insulin Ratio CIR is calculated by the following formula: <br />CIR=(CIR from Lunch)/AF (44)
0234The Meal-by-Meal with Carb-Counting process <b>1300</b> routes the CIR to block <b>1340</b> where the Recommended Dinner Bolus is calculated as follows: <br />RecDinnerBol=(Carbohydrate gms in Dinner)/CIR (45)
0235The Carbohydrate-to-Insulin Ratio CIR is also sent from block <b>1336</b> to block <b>1332</b> for use in the upcoming Breakfast calculations. The process <b>1300</b> sends the Recommended Dinner Bolus, RecomDinnerBol to the remote processor at block <b>1354</b>, and to the display <b>114</b>, <b>146</b>, block <b>1352</b>.
0236If the process <b>1300</b> determines the blood glucose BG at block <b>1310</b> to not be a pre-Dinner BG, then the process <b>1300</b> routes the blood glucose BG to block <b>1312</b>. If the process <b>1300</b> determines the blood glucose BG at block <b>1312</b> to be a Bedtime BG, then the process <b>1300</b> routes the blood glucose BG to block <b>1330</b>, where it is used as the input (BG<sub>gov</sub>) for the AF Function. The AF Function returns a value of the Adjustment Factor (AF), which is routed to block <b>1332</b>, where the Carbohydrate-to-Insulin Ratio (CIR) is calculated by the following formula at block <b>1334</b>: <br />CIR=(CIR from Dinner)/AF (46)
0237The Meal-by-Meal with Carb-Counting process <b>1300</b> routes the CIR to block <b>1336</b> where the Recommended Breakfast Bolus is calculated as follows: <br />RecBreakfastBol=(Carbohydrate gms in Breakfast)/CIR (47)
0238The CIR is also sent from block <b>1330</b> to block <b>1334</b> for use in the upcoming Lunch calculations. The process <b>1300</b> sends the Recommended Breakfast Bolus to the remote processor at block <b>1354</b>, and to the Subject Data Display at block <b>1352</b>.
0239<figref idref="DRAWINGS">FIG. 14</figref> shows a subcutaneous process <b>1400</b> for non-diabetic patients <b>10</b> who have a temporary condition of diabetes-like symptoms. A typical example is stress-hyperglycemia, a condition that is encountered when the patient's body is under stress due to surgery, certain medications, or another disease other than diabetes. The stress causes the patient's body to react by raising the blood glucose. As the patient recovers, this hyperglycemic condition typically disappears, sometimes rapidly, leaving the patient without need of insulin. The principle of the process is to rapidly reduce the entire insulin dosing regimen of the patient by a factor NonDMfactor, whenever a blood glucose measurement BG falls below a threshold.
0240The Non-DM process <b>1400</b> begins at block <b>1402</b> with a blood glucose measurement BG. The process <b>1400</b> determines at block <b>1460</b> if the blood glucose BG is below a threshold for insulin reduction NonDMfloor. If the blood glucose BG is less than the values of the last recommended NonDMfloor, the process <b>1400</b> reduces, at block <b>1462</b>, the value of all the last-recommended insulin doses in a table at block <b>1463</b>, by multiplying each value by a dimensionless configurable constant whose value is between 0 and 1, threshold for insulin reduction NonDMfactor. The group at block <b>1463</b> includes the last-recommended-doses such as Breakfast Bolus BG<sub>Breakfast</sub>, Lunch Bolus BG<sub>Lunch</sub>, Dinner Bolus BG<sub>Dinner</sub>, and Basal Dose, irrespective of whether the dose has been given or not. In other words, the latest recommendation (or prescribed dose) is changed whether a dose was given or not. In many implementations, the threshold for insulin reduction NonDMfactor is configured to a value of 0.5.
0241Corrective insulin may also be reduced. This is accomplished by raising the Correction Factor CF as follows: Returning to block <b>1462</b>, the logic is passed to block <b>1464</b>, where a value of Total Daily Dose of Insulin TDD is recalculated each time the dose is reduced. This is accomplished by summing all the newly-reduced values of the last recommended values of meal boluses and basal doses. The process <b>1400</b> passes the TDD to block <b>1466</b>, where a live Correction Factor is calculated as follows: <br />CF=CFR/TDD (46)
0242Returning to block <b>1402</b>, the process <b>1400</b> routes the blood glucose BG to block <b>1404</b> where the process <b>1400</b> determines if the blood glucose type BG<sub>type </sub>is MidSleep BG<sub>Midsleep</sub>. If so, then the process <b>1400</b> routes the MidSleep blood glucose BG<sub>Midsleep </sub>to block <b>1442</b>. If it is determined at block <b>1404</b> that the blood glucose type BG<sub>type </sub>is not MidSleep, the logic is passed to block <b>1406</b>, where it is determined if the blood glucose type BG<sub>type </sub>is pre-Breakfast BG<sub>Breakfast</sub>. If the blood glucose type BG<sub>type </sub>is pre-Breakfast BG<sub>Breakfast</sub>, the process <b>1400</b> calculates a Correction dose CB at block <b>1416</b> and is administered as soon as possible. Also, if blood glucose type BG<sub>type </sub>is pre-Breakfast BG<sub>Breakfast</sub>, the logic is passed to box <b>1424</b>, where the previously-recommended Breakfast meal bolus is administered. The value of this previously-recommended pre-Breakfast meal bolus is passed to block <b>1436</b>, where it is one of the two required parameters for calculation of the Next Recommended Breakfast Bolus. Returning to block <b>1406</b>, the process <b>1400</b> routes the pre-Breakfast BG to box <b>1450</b>.
0243The condition at block <b>1450</b> is that the administration of basal is blocked by not-posting the recommended Basal dose until the arrival of the breakfast blood glucose BG<sub>Breakfast </sub>from block <b>1406</b>, where the pre-breakfast blood glucose BG<sub>Breakfast </sub>is sent to block <b>1442</b>. At block <b>1442</b>, the process <b>1400</b> determines the governing blood glucose BG<sub>gov </sub>for Basal adjustment as the lesser of the two blood glucose values, midsleep blood glucose BG<sub>Midsleep </sub>and pre-breakfast blood glucose BG<sub>Breakfast</sub>. At block <b>1444</b>, the process <b>1400</b> inputs the governing blood glucose BG<sub>gov </sub>for Basal into the Adjustment Factor AF Function (<figref idref="DRAWINGS">FIG. 7</figref>), which returns an Adjustment Factor AF for basal adjustment. The process <b>1400</b> sends the adjustment factor AF to block <b>1446</b>, where it is used to calculate the Recommended First Basal Dose of the day by the formula: <br />Recommended first Basal Dose=AF*(Previous day's last Basal Dose) (48)
0244Basal dosing is adjusted only once per day, because a fasting blood glucose BG is needed as the governing blood glucose BG<sub>gov</sub>, and the midsleep blood glucose BG<sub>Midsleep </sub>and pre-breakfast blood glucose BG<sub>Breakfast </sub>BG are the only reliable fasting blood glucose measurements BG during the day. If more than one basal dose is used, then the values are set to be equal to the first basal dose of the day. The last basal dose of the day is used as the Governing Basal Dose because it is the most recent dose at the time of the midsleep blood glucose BG<sub>Midsleep </sub>and pre-breakfast blood glucose BG<sub>Breakfast</sub>.
0245If the process <b>1400</b> determines at block <b>1406</b> that the Blood Glucose type BG<sub>type </sub>is not Breakfast, the logic passes to block <b>1408</b>, where the process <b>1400</b> determines if the BG<sub>type </sub>is Lunch. If the BG<sub>type </sub>is Lunch, the process <b>1400</b> calculates a Correction dose CB at block <b>1418</b>, which is administered as soon as possible. Also, the logic passes to box <b>1426</b>, where the previously-recommended Lunch meal bolus is administered. The process <b>1400</b> passes the value of this previously-recommended Lunch meal bolus to block <b>1438</b>, where it is one of the two required parameters for calculation of the Next Recommended Lunch Bolus. Returning to block <b>1408</b>, the process <b>1400</b> also routes the lunch blood glucose BG<sub>lunch </sub>to block <b>1430</b>, providing the second of the two required parameters for calculation of the Next Recommended Breakfast Bolus as follows: <br />Next Recom. Breakfast Bolus=AF*(Current Recom Breakfast Bolus) (49)
0246If it is determined at block <b>1408</b> that BG<sub>type </sub>is not pre-Lunch, the logic passes to block <b>1410</b>, where the process <b>1400</b> determines if the BG<sub>type </sub>is pre-Dinner. If the BG<sub>type </sub>is pre-Dinner, the process <b>1400</b> calculates a Correction dose at block <b>1420</b>, which is administered as soon as possible. Also, the logic is passes to box <b>1428</b>, where the previously-recommended Dinner meal bolus is administered. The value of this previously-recommended Dinner meal bolus is passed to box <b>1440</b>, where is one of the two required parameters for calculation of the Next Recommended Dinner Bolus. Returning to block <b>1410</b>, the process <b>1400</b> also routes the pre-Dinner blood glucose BG<sub>Dinner </sub>to block <b>1432</b>, providing the second of the two required parameters for calculation of the Next Recommended Lunch Bolus as follows: <br />Next Recom. Lunch Bolus=AF*(Current Recom Lunch Bolus) (50)
0247If it is determined at block <b>1410</b> that BG<sub>type </sub>is not pre-Dinner, the logic passes to block <b>1412</b>, where the process <b>1400</b> determines if the BG<sub>type </sub>is Bedtime. If the blood glucose type BG<sub>type </sub>is Bedtime, the process <b>1400</b> calculates a Correction dose CB at block <b>1422</b>, which is administered as soon as possible. Also, the logic passes to box <b>1434</b>, providing the second of the two required parameters for calculation of the Next Recommended Dinner Bolus as follows: <br />Next Recom. Dinner Bolus=AF*(Current Recom Dinner Bolus) (51)
0248If it is determined at block <b>1412</b> that the blood glucose BG<sub>type </sub>is not Bedtime, the logic passes to block <b>1456</b>, where the process <b>1400</b> determines if the BG<sub>type </sub>is Bedtime. If the BG<sub>type </sub>is Bedtime, the process <b>1400</b> calculates a Correction dose at block <b>1458</b>, which is administered as soon as possible. The process <b>1400</b> sends the next recommended meal bolus to the remote processor at block <b>1454</b>, and to the display <b>114</b>, <b>146</b>, at block <b>1452</b>.
0249<figref idref="DRAWINGS">FIG. 15</figref> provides an arrangement of operations for a method <b>1500</b> of administering intravenous insulin to a patient <b>10</b>. The method includes receiving <b>1502</b> blood glucose measurements BG on a computing device (e.g., a processor <b>112</b> of a patient device <b>110</b>, a processor <b>152</b> of a hospital electronic medical record system <b>150</b>, or a data processor <b>132</b> of a service provider <b>130</b>) of a dosing controller <b>160</b> from a blood glucose measurement device <b>124</b> (e.g., glucose meter or glucometer). The blood glucose measurements BG are separated by a time interval T<sub>Next</sub>. The method <b>1500</b> includes determining <b>1504</b>, using the computing device <b>112</b>, <b>132</b>, <b>142</b>, an insulin dose rate IIR based on the blood glucose measurements BG. In some implementations, the method <b>1500</b> determines the insulin dose rate IRR based on the current blood glucose measurement BG, a constant K, and a multiplier M (see EQ. 3A above). The constant K may equal 60 mg/dl. The method <b>1500</b> includes leaving the multiplier M unchanged between time intervals T<sub>Next </sub>when the current blood glucose measurement BG is greater than an upper limit BG<sub>TRH </sub>of the blood glucose target range BG<sub>TR </sub>and the blood glucose percent drop BG<sub>% Drop </sub>from the previous blood glucose value BG<sub>P </sub>is greater than or equal to a desired percent drop BG % dropM (see EQ. 5). The method also includes multiplying the multiplier M by a change factor M<sub>CF </sub>when the current blood glucose measurement BG is greater than an upper limit BG<sub>TRH </sub>of the blood glucose target range BG<sub>TR </sub>and the blood glucose percent drop BG<sub>% Drop </sub>(or blood glucose percent drop) is less than the desired percent drop BG % dropM. Additionally or alternatively, the method <b>1500</b> includes leaving the multiplier M unchanged between time intervals T<sub>Next </sub>when the current blood glucose measurement BG is in the target range BG<sub>TR </sub>i.e. when BG is less than an upper limit BG<sub>TRH </sub>of the blood glucose target range and greater than the lower limit BG<sub>TRL </sub>of the target range, BG<sub>TR</sub>. The method also includes dividing the multiplier M by a change factor M<sub>CF </sub>when the current blood glucose measurement BG is less than the lower limit BG<sub>TRL </sub>of the blood glucose target range BG<sub>TR</sub>.
0250The method <b>1500</b> may include setting the time interval T<sub>Next </sub>to a hypoglycemia time interval T<sub>Hypo </sub>of between about 15 minutes and about 30 minutes, when the current blood glucose measurement BG is below a hypo-threshold blood glucose level BG<sub>Hypo</sub>.
0251The method <b>1500</b> includes determining <b>1506</b> a blood glucose drop rate BG<sub>DropRate </sub>based on the blood glucose measurements BG and the time interval T<sub>Next</sub>. The method <b>1500</b> includes determining <b>1507</b> a blood glucose percent drop BG<sub>% Drop</sub>, using the computing device <b>112</b>, <b>132</b>, <b>142</b> from a previous blood glucose measurement BG<sub>p</sub>. When the blood glucose drop rate BG<sub>DropRate </sub>is greater than a threshold drop rate BG<sub>DropRateLimit</sub>, the method <b>1500</b> includes decreasing at <b>1508</b> the time interval T<sub>Next </sub>between blood glucose measurements measure by the glucometer.
0252The method <b>1500</b> also includes decreasing <b>1510</b> the time interval T<sub>Next </sub>between blood glucose measurements BG when the percent drop BG<sub>% Drop </sub>of the blood glucose BG is greater than the threshold of the percent drop % Drop<sub>Regular</sub>, where the threshold of the percent drop % Drop<sub>Regular </sub>depends on whether the current blood glucose measurement BG is below a lower limit BG<sub>TRL </sub>of a blood glucose target range BG<sub>TR</sub>. In some implementations, the method <b>1500</b> includes decreasing the time interval T<sub>Next </sub>when the current blood glucose measurement BG is greater than or equal to the lower limit BG<sub>TRL </sub>of the blood glucose target range BG<sub>TR </sub>and the blood glucose percent drop BG<sub>% Drop </sub>exceeds a threshold percent drop % Drop<sub>Regular</sub>. In some implementations, the method <b>1500</b> includes decreasing the time interval T<sub>Next </sub>when the current blood glucose measurement BG is below the lower limit BG<sub>TRL </sub>of the blood glucose target range BG<sub>TR </sub>and above the hypo-threshold blood glucose level BG<sub>Hypo</sub>, and the blood glucose percent drop BG<sub>% Drop </sub>is greater than or equal to a threshold percent drop % Drop<sub>LowLimit</sub>.
0253In some examples, the method <b>1500</b> includes leaving the multiplier M unchanged for at least two subsequent time intervals, T<sub>Next</sub>, when the current blood glucose measurement BG is a pre-meal measurement. In some examples, the method <b>1500</b> includes receiving, on the computing device <b>112</b>, <b>132</b>, <b>142</b>, a number of carbohydrates for a meal as well as a blood glucose measurement, and determining, using the computing device <b>112</b>, <b>132</b>, <b>142</b>, an intravenous insulin rate IIR based on the blood glucose (this IIR may be calculated using EQ. 3A). In addition, the method <b>1500</b> includes determining, using the computing device <b>112</b>, <b>132</b>, <b>142</b>, a meal bolus insulin rate IIR based on the number of carbohydrates. The method <b>1500</b> then calculates a Total insulin rate as the sum of the meal bolus rate and the regular intravenous rate as shown in EQ. 12. The method <b>1500</b> may further include setting the time interval T<sub>Next </sub>to about 30 minutes. If the blood glucose measurement BG is a second consecutive measurement after (but not including) an initial pre-meal blood glucose measurement BG, the method <b>1500</b> includes setting the time interval T<sub>Next </sub>to about 30 minutes.
0254In some implementations, the method <b>1500</b> includes electronically displaying on a display <b>116</b>, <b>146</b> a warning and blocking transition to a subcutaneous administration of insulin when the current blood glucose measurement BG is outside a stability target range BG<sub>STR</sub>. In addition, the method <b>1500</b> includes electronically displaying on the display <b>116</b>, <b>146</b> a warning when the current blood glucose measurement BG is within the patient's personalized target range BG<sub>TR </sub>for less than a threshold stability period of time T<sub>Stable</sub>. In some examples, the method <b>1500</b> includes determining a total daily dose of insulin TDD based on the multiplier M when the current blood glucose measurement BG is within a stability target range BG<sub>STR </sub>for a threshold stability period of time T<sub>Stable</sub>.
0255Referring to <figref idref="DRAWINGS">FIG. 16</figref>, a method <b>1600</b> of administering insulin includes receiving <b>1602</b> blood glucose measurements BG of a patient <b>10</b> at a data processing device <b>112</b> from a glucometer <b>124</b>. The blood glucose measurements BG are separated by a time interval T<sub>Next</sub>. The method <b>1600</b> also includes receiving <b>1604</b> patient information at the data processing device <b>112</b>, and in some examples, storing the received patient information on non-transitory memory <b>24</b>, <b>114</b>, <b>144</b> associated with the processor <b>112</b>. The method <b>1600</b> includes receiving <b>1606</b> a selection <b>226</b>, at the data processing device <b>112</b>, of a subcutaneous insulin treatment <b>900</b>, <b>1000</b>, <b>1100</b>, <b>1200</b>, <b>1300</b>, <b>1400</b> from a collection of subcutaneous insulin treatments <b>900</b>, <b>1000</b>, <b>1100</b>, <b>1200</b>, <b>1300</b>, <b>1400</b>. The selection <b>226</b> is based on the blood glucose measurements BG and the patient information <b>208</b><i>a</i>. The method <b>1600</b> also includes executing <b>1608</b>, using the data processing device <b>112</b>, the selected subcutaneous insulin treatment <b>900</b>, <b>1000</b>, <b>1100</b>, <b>1200</b>, <b>1300</b>, <b>1400</b>.
0256In some implementations, the method <b>1600</b> includes: receiving a configurable constant CFR; storing the configurable constant CFR in non-transitory memory associated with the data processing device; and determining a correction factor. The configurable constant CFR may be determined from a published statistical correlation. The method <b>1600</b> may also include determining a pre-meal correction bolus CB, and/or a post-prandial correction bolus CB. The method <b>1600</b> may include receiving a half-life value of the rapid-acting insulin; and determining the mean lifetime iLifeRapid of the rapid-acting insulin.
0257In some implementations, the method <b>1600</b> includes receiving a governing blood glucose value BG<sub>gov</sub>, and determining an adjustment factor AF based on the received governing blood glucose value BG<sub>gov</sub>. Determining the adjustment factor AF may include determining when the governing blood glucose value BG<sub>gov </sub>is within a threshold range of values, and setting the adjustment factor to a preconfigured adjustment factor based on the threshold range of values. In some implementations, the method <b>1600</b> includes determining a Carbohydrate-to-Insulin Ratio CIR based on the adjustment factor AF by calculating one of EQs. 42, 44, and 46.
0258The selection of subcutaneous insulin treatments <b>900</b>, <b>1000</b>, <b>1100</b>, <b>1200</b>, <b>1300</b>, <b>1400</b> includes one or more of a subcutaneous standard program <b>900</b>, a subcutaneous for tube-fed patients program <b>1000</b>, a subcutaneous program without meal boluses <b>1100</b>, a meal-by-meal subcutaneous program without carbohydrate counting <b>1200</b>, a meal-by-meal subcutaneous program with carbohydrate counting <b>1300</b>, and a subcutaneous program for non-diabetic patients <b>1400</b>. In some examples, the subcutaneous for tube-fed patients process <b>1000</b> includes: receiving a blood glucose time BG<sub>Time </sub>associated with a time of measuring of the blood glucose measurement BG; determining if the blood glucose time BG<sub>Time </sub>is within a threshold time interval; setting a timer <b>1001</b>, <b>1101</b> for a next blood glucose measurement BG based on the threshold time interval; and determining a correction insulin dose CB based on the blood glucose type BG<sub>Type</sub>.
0259In some examples, the standard program <b>900</b> includes determining a blood glucose type BG<sub>Type </sub>of the received blood glucose measurement BG; and determining a correction insulin dose CB based on the blood glucose type BG<sub>Type</sub>. In some examples, the method <b>1600</b> includes receiving a governing blood glucose value BG<sub>gov</sub>, and determining an adjustment factor AF based on the received governing blood glucose value and the blood glucose measurement. The method <b>1600</b> may also include determining a next recommended meal bolus based on the determined adjustment factor AF and a current recommended meal bolus.
0260Various implementations of the systems and techniques described here can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. These various implementations can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.
0261These computer programs (also known as programs, software, software applications or code) include machine instructions for a programmable processor and can be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the terms “machine-readable medium” and “computer-readable medium” refer to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term “machine-readable signal” refers to any signal used to provide machine instructions and/or data to a programmable processor.
0262Implementations of the subject matter and the functional operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Moreover, subject matter described in this specification can be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a computer readable medium for execution by, or to control the operation of, data processing apparatus. The computer readable medium can be a machine-readable storage device, a machine-readable storage substrate, a memory device, a composition of matter affecting a machine-readable propagated signal, or a combination of one or more of them. The terms “data processing apparatus”, “computing device” and “computing processor” encompass all apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, or multiple processors or computers. The apparatus can include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them. A propagated signal is an artificially generated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus.
0263A computer program (also known as an application, program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.
0264The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform functions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatus can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application specific integrated circuit).
0265Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read only memory or a random access memory or both. The essential elements of a computer are a processor for performing instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio player, a Global Positioning System (GPS) receiver, to name just a few. Computer readable media suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto optical disks; and CD ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry.
0266To provide for interaction with a user, one or more aspects of the disclosure can be implemented on a computer having a display device, e.g., a CRT (cathode ray tube), LCD (liquid crystal display) monitor, or touch screen for displaying information to the user and optionally a keyboard and a pointing device, e.g., a mouse or a trackball, by which the user can provide input to the computer. Other kinds of devices can be used to provide interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including acoustic, speech, or tactile input. In addition, a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; for example, by sending web pages to a web browser on a user's client device in response to requests received from the web browser.
0267One or more aspects of the disclosure can be implemented in a computing system that includes a backend component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a frontend component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such backend, middleware, or frontend components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
0268The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some implementations, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server.
0269While this specification contains many specifics, these should not be construed as limitations on the scope of the disclosure or of what may be claimed, but rather as descriptions of features specific to particular implementations of the disclosure. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination.
0270Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multi-tasking and parallel processing may be advantageous. Moreover, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.
0271A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other implementations are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results.
Contents6
44 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22 Sheet 23 Sheet 24 Sheet 25 Sheet 26 Sheet 27 Sheet 28 Sheet 29 Sheet 30 Sheet 31 Sheet 32 Sheet 33 Sheet 34 Sheet 35 Sheet 36 Sheet 37 Sheet 38 Sheet 39 Sheet 40 Sheet 41 Sheet 42 Sheet 43 Sheet 44
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| US11941097B2 | Cited by | United States of America | Applicant |
| US12109392B2 | Cited by | United States of America | Applicant |
| US10842935B2 | Cited by | United States of America | Applicant |
| US12249425B2 | Cited by | United States of America | Applicant |
| WO0236139A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO03024468A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO03077895A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO03094927A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO03101177A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| EP0461207A1 | Cites | European Patent Office (EPO) | Applicant |
| EP0483595A2 | Cites | European Patent Office (EPO) | Applicant |
| EP0557350A1 | Cites | European Patent Office (EPO) | Applicant |
| EP0573499A1 | Cites | European Patent Office (EPO) | Applicant |
| EP0768043A2 | Cites | European Patent Office (EPO) | Applicant |
| EP0862648A1 | Cites | European Patent Office (EPO) | Applicant |
| EP0910578A2 | Cites | European Patent Office (EPO) | Applicant |
| EP0925792A2 | Cites | European Patent Office (EPO) | Applicant |
| EP1017414A1 | Cites | European Patent Office (EPO) | Applicant |
| CN102016855A | Cites | China | Applicant |
| CN102016906A | Cites | China | Applicant |
| CN102300501A | Cites | China | Applicant |
| CN102395310A | Cites | China | Applicant |
| CN102481101A | Cites | China | Applicant |
| CN102946804A | Cites | China | Applicant |
| EP1030557A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1051141A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1067925A1 | Cites | European Patent Office (EPO) | Applicant |
| DE1082412T1 | Cites | Germany | Applicant |
| EP1115389A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1173482A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1185321A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1196445A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1214596A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1305018A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1317190A2 | Cites | European Patent Office (EPO) | Applicant |
| EP1382363A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1424074A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1482919A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1581095A2 | Cites | European Patent Office (EPO) | Applicant |
| EP1610758A2 | Cites | European Patent Office (EPO) | Applicant |
| EP1679009A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1698898A2 | Cites | European Patent Office (EPO) | Applicant |
| EP1773860A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1846002A1 | Cites | European Patent Office (EPO) | Applicant |
| EP1885392A2 | Cites | European Patent Office (EPO) | Applicant |
| EP1915171A2 | Cites | European Patent Office (EPO) | Applicant |
| EP1921981A2 | Cites | European Patent Office (EPO) | Applicant |
| US2001002269A1 | Cites | United States of America | Applicant |
| US2003028089A1 | Cites | United States of America | Applicant |
| US2003050621A1 | Cites | United States of America | Applicant |
| US2003199445A1 | Cites | United States of America | Applicant |
| US2003208110A1 | Cites | United States of America | Applicant |
| US2004042272A1 | Cites | United States of America | Applicant |
| US2004044272A1 | Cites | United States of America | Applicant |
| US2004054263A1 | Cites | United States of America | Applicant |
| WO2004084820A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2005020681A1 | Cites | United States of America | Applicant |
| WO2005041022A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2005049179A1 | Cites | United States of America | Applicant |
| US2005054818A1 | Cites | United States of America | Applicant |
| US2005055010A1 | Cites | United States of America | Applicant |
| WO2005081119A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2005081170A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2005081171A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2005081173A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2005096637A1 | Cites | United States of America | Applicant |
| WO2005110222A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2005171503A1 | Cites | United States of America | Applicant |
| US2005176621A1 | Cites | United States of America | Applicant |
| US2005177398A1 | Cites | United States of America | Applicant |
| US2005187749A1 | Cites | United States of America | Applicant |
| US2005192494A1 | Cites | United States of America | Applicant |
| US2005192557A1 | Cites | United States of America | Applicant |
| US2005197621A1 | Cites | United States of America | Applicant |
| US2005267195A1 | Cites | United States of America | Applicant |
| US2005272640A1 | Cites | United States of America | Applicant |
| WO2006022619A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2006022629A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2006022633A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2006022634A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2006022636A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2006022638A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2006040003A1 | Cites | United States of America | Applicant |
| WO2006044556A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2006078593A1 | Cites | United States of America | Applicant |
| WO2006079124A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2006091918A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2006130901A1 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2006160722A1 | Cites | United States of America | Applicant |
| US2006173260A1 | Cites | United States of America | Applicant |
| US2006188995A1 | Cites | United States of America | Applicant |
| US2006224109A1 | Cites | United States of America | Applicant |
| US2006264895A1 | Cites | United States of America | Applicant |
| US2007036872A1 | Cites | United States of America | Applicant |
| US2007060796A1 | Cites | United States of America | Applicant |
| US2007078314A1 | Cites | United States of America | Applicant |
| US2007078818A1 | Cites | United States of America | Applicant |
| WO2007116226A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| WO2007149533A2 | Cites | World Intellectual Property Organization (WIPO) | Applicant |
| US2007160678A1 | Cites | United States of America | Applicant |
102 members in 8 offices
Priority claims5
| Document | Office | Kind | Date |
|---|---|---|---|
| 201461934300 | United States of America | P | |
| 201462009575 | United States of America | P | |
| 201414524918 | United States of America | A | |
| 201514938997 | United States of America | A | |
| 201615342606 | United States of America | A |
Members102
| Document | Office | Kind | |
|---|---|---|---|
| CA2926761A1 | Canada | A1 | |
| CA2927855A1 | Canada | A1 | |
| CA2928737A1 | Canada | A1 | |
| US2015217053A1 | United States of America | A1 | |
| US2015217054A1 | United States of America | A1 | |
| US2015217055A1 | United States of America | A1 | |
| WO2015116371A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2015116397A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO2015116401A1 | World Intellectual Property Organization (WIPO) | A1 | |
| US9233204B2 | United States of America | B2 | |
| US2016058944A1 | United States of America | A1 | |
| AU2015211352A1 | Australia | A1 | |
| AU2015211378A1 | Australia | A1 | |
| AU2015211382A1 | Australia | A1 | |
| EP3046599A1 | European Patent Office (EPO) | A1 | |
| EP3046600A1 | European Patent Office (EPO) | A1 | |
| EP3046601A1 | European Patent Office (EPO) | A1 | |
| IL246937A0 | Israel | A0 | |
| IL246937D0 | Israel | D0 | |
| IL246936A0 | Israel | A0 | |
| IL246936D0 | Israel | D0 | |
| IL246939A0 | Israel | A0 | |
| IL246939D0 | Israel | D0 | |
| US9486580B2 | United States of America | B2 | |
| US9504789B2 | United States of America | B2 | |
| US2017007761A1 | United States of America | A1 | |
| JP2017505695A | Japan | A | |
| JP2017505696A | Japan | A | |
| IL246936A | Israel | A | |
| IL246939A | Israel | A | |
| JP2017506757A | Japan | A | |
| US2017068802A1 | United States of America | A1 | |
| US2017076067A1 | United States of America | A1 | |
| US9604002B2 | United States of America | B2 | |
| EP3046601A4 | European Patent Office (EPO) | A4 | |
| HK1222349A | Hong Kong, China | A | |
| HK1222349A1 | Hong Kong, China | A1 | |
| HK1222357A | Hong Kong, China | A | |
| HK1222357A1 | Hong Kong, China | A1 | |
| EP3046600A4 | European Patent Office (EPO) | A4 | |
| US9710611B2 | United States of America | B2 | |
| EP3046599A4 | European Patent Office (EPO) | A4 | |
| US2017281098A1 | United States of America | A1 | |
| US9892235B2 | United States of America | B2 | |
| US9898585B2 | United States of America | B2 | |
| US2018122505A1 | United States of America | A1 | |
| US9965595B2 | United States of America | B2 | |
| US2018144818A1 | United States of America | A1 | |
| US2018226149A1 | United States of America | A1 | |
| US2018366217A1 | United States of America | A1 | |
| US10255992B2This record | United States of America | B2 | |
| AU2015211352B2 | Australia | B2 | |
| JP6511072B2 | Japan | B2 | |
| AU2015211378B2 | Australia | B2 | |
| US2019180858A1 | United States of America | A1 | |
| JP6539290B2 | Japan | B2 | |
| US10453568B2 | United States of America | B2 | |
| JP6602784B2 | Japan | B2 | |
| AU2015211382B2 | Australia | B2 | |
| JP2019213866A | Japan | A | |
| US10535426B2 | United States of America | B2 | |
| US2020027544A1 | United States of America | A1 | |
| IL246937A | Israel | A | |
| IL246937B | Israel | B | |
| US2020219607A1 | United States of America | A1 | |
| US10811133B2 | United States of America | B2 | |
| US2021020298A1 | United States of America | A1 | |
| US2021151183A1 | United States of America | A1 | |
| JP6882383B2 | Japan | B2 | |
| EP3046599B1 | European Patent Office (EPO) | B1 | |
| US11081233B2 | United States of America | B2 | |
| US11158424B2 | United States of America | B2 | |
| EP3926638A1 | European Patent Office (EPO) | A1 | |
| EP3926638A4 | European Patent Office (EPO) | A4 | |
| US2022037016A1 | United States of America | A1 | |
| US11311213B2 | United States of America | B2 | |
| CA2927855C | Canada | C | |
| CA2928737C | Canada | C | |
| US2022248989A1 | United States of America | A1 | |
| US11468987B2 | United States of America | B2 | |
| US11490837B2 | United States of America | B2 | |
| US2022359072A1 | United States of America | A1 | |
| US2022399111A1 | United States of America | A1 | |
| CA2926761C | Canada | C | |
| US2023087860A1 | United States of America | A1 | |
| US11621074B2 | United States of America | B2 | |
| US2023238132A1 | United States of America | A1 | |
| US11783945B2 | United States of America | B2 | |
| US11783946B2 | United States of America | B2 | |
| US11804300B2 | United States of America | B2 | |
| US11857314B2 | United States of America | B2 | |
| US2024013913A1 | United States of America | A1 | |
| US2024041357A1 | United States of America | A1 | |
| US2024055119A1 | United States of America | A1 | |
| US12027266B2 | United States of America | B2 | |
| US2024335145A1 | United States of America | A1 | |
| US12127831B2 | United States of America | B2 | |
| US2024412863A1 | United States of America | A1 | |
| US12288620B2 | United States of America | B2 | |
| EP3926638B1 | European Patent Office (EPO) | B1 |
60 transactions on the USPTO file
Allowed after 1 non-final rejection.
- Non-final rejections
- 1
- Final rejections
- 0
- RCEs
- 0
- Appeals
- 0
Over time
Point at a mark for the transactionTransactions
| Event | Code | |
|---|---|---|
| Payment of Maintenance Fee, 4th Yr, Small EntityM2551 | M2551 | |
| Recordation of Patent Grant MailedPGM/ | PGM/ | |
| Patent Issue Date Used in PTA CalculationAllowedPTAC | PTAC | |
| Issue Notification MailedAllowedWPIR | WPIR | |
| Dispatch to FDCD1935 | D1935 | |
| Application Is Considered Ready for IssuePILS | PILS | |
| Response to Reasons for AllowanceREAS | REAS | |
| Issue Fee Payment VerifiedN084 | N084 | |
| Issue Fee Payment ReceivedIFEE | IFEE | |
| Mail Examiner's AmendmentMEX.A | MEX.A | |
| Examiner's Amendment CommunicationEX.A | EX.A | |
| Printer Rush- No mailingTCPB | TCPB | |
| Printer Rush- No mailingTCPB | TCPB | |
| Printer Rush- No mailingTCPB | TCPB | |
| Mail Interview Summary - Examiner Initiated - TelephonicMEXET | MEXET | |
| Interview Summary - Examiner Initiated - TelephonicEXET | EXET | |
| Pubs Case Remand to TCPUBTC | PUBTC | |
| Mail Notice of AllowanceAllowedMN/=. | MN/=. | |
| Notice of Allowance Data Verification CompletedAllowedN/=. | N/=. | |
| Reasons for AllowanceEX.R | EX.R | |
| track 1 ONT1ON | T1ON | |
| Date Forwarded to ExaminerFWDX | FWDX | |
| Response after Non-Final ActionA... | A... | |
| Application ready for PDX access by participating foreign officesCCRDY | CCRDY | |
| PG-Pub Issue NotificationPG-ISSUE | PG-ISSUE | |
| Paralegal or electronic terminal disclaimer approvedP574 | P574 | |
| Terminal Disclaimer FiledDIST | DIST | |
| Mail Non-Final RejectionNon-final rejectionMCTNF | MCTNF | |
| Non-Final RejectionNon-final rejectionCTNF | CTNF | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Mail Pet Dec Track 1 GrantMPDTG | MPDTG | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Track 1 Request GrantedT1GR | T1GR | |
| Mail-Record Petition Decision of Granted to Make SpecialMP003 | MP003 | |
| Record Petition Decision of Granted to Make SpecialP003 | P003 | |
| Pet Dec Track 1 GrantPDTG | PDTG | |
| Application Dispatched from OIPEOIPE | OIPE | |
| FITF set to YES - revise initial settingFTFS | FTFS | |
| Application Is Now CompleteCOMP | COMP | |
| Filing ReceiptFLRCPT.O | FLRCPT.O | |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27SMAL | SMAL | |
| Cleared by OIPE CSRL194 | L194 | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Patent Term Adjustment - Ready for ExaminationPTA.RFE | PTA.RFE | |
| PTO/SB/69-Authorize EPO Access to Search ResultsSREXR141 | SREXR141 | |
| Applicants have given acceptable permission for participating foreignAPPERMS | APPERMS | |
| Track 1 RequestTK1R | TK1R | |
| Petition EnteredPET. | PET. | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| IFW Scan & PACR Auto Security ReviewSCAN | SCAN | |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change)BIG. | BIG. | |
| Initial Exam Team nnIEXX | IEXX |
13 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| Maintenance fee paymentMAFP | MAFP | |
| AssignmentAS | AS | |
| Information on status: patent grantGrantedPATENTED CASESTCF | STCF | |
| Fee payment procedureENTITY STATUS SET TO SMALL (ORIGINAL EVENT CODE: SMAL); ENTITY STATUS OF PATENT OWNER: SMALL ENTITYFEPP | FEPP | |
| AssignmentAS | AS | |
| Fee payment procedureENTITY STATUS SET TO UNDISCOUNTED (ORIGINAL EVENT CODE: BIG.); ENTITY STATUS OF PATENT OWNER: SMALL ENTITYFEPP | FEPP |
Numbers
- Publication
- 10255992
- Application
- 15942740
Titles
- English
- Insulin management
Patent term adjustment
- Net adjustment
- 0 days
Classification
- CPC, 29
- G16H20/60
- G16H40/67
- A61M2005/14296
- A61B5/14532
- A61M2005/14208
- A61M5/1723
- A61B5/4839
- A61M5/14
- A61M2005/1726
- G06F19/00
- A61M2205/3584
- G06F19/3418
- A61M2205/3592
- G06F19/3468
- A61B5/4848
- G16H10/40
- G16H20/17
- A61M2205/52
- A61P3/10
- G16H80/00
- A61M2205/18
- A61M2205/3327
- A61M2205/50
- A61M2205/35
- A61M2230/201
- A61M2205/3553
- A61M2205/502
- A61M2205/507
- A61M2205/581
- IPC, 12
- G01N33 48
- G16H20 60
- A61M5 172
- A61B5 145
- G06F19 00
- A61B5 00
- A61M5 14
- G16H20 17
- G16H40 67
- G16H80 00
- G16H10 40
- A61M5 142